Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Description: The battery is an accessory for insulin pump use. it is the main power of DANA insulin pump.
SOOIL DEVELOPMENT CO.,LTD
Bobbin
In Commercial Distribution

  • 08809220581014 ()
  • 08809220581021 ()


  • Ambulatory insulin infusion pump, electronic
Light Reddish Pink. This is sold as part of the 11-Unit Package (688303) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
In Commercial Distribution

  • D0019883980 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Pink. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800510 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin
The Midmark Drain Pan is intended for lower body procedures or situations where fluid and debris removal is necessary.
MIDMARK CORPORATION
9A556001
In Commercial Distribution

  • 00841709117978 ()
9A556001

  • General examination/treatment chair, electric
The k-wire washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel.
Ascension Orthopedics, Inc.
12220025
In Commercial Distribution

  • 10381780124986 ()

  • .394 in dia x .039 in H
12220025

  • External orthopaedic fixation system, reusable
EchoMark is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
SONAVEX, INC.
3000
In Commercial Distribution

  • B53630001 ()

  • Large


  • Radiological image marker, implantable
The specfication of electrodes is 50*50 and it is packed with transparent plastic bag (20 pieces) bold line
Wuxi Jiajian Medical Instrument Co.,Ltd.
11G-2101-U
In Commercial Distribution

  • 16972011716533 ()
  • 06972011716536 ()


  • Acupuncture needle, single-use
Disposable fluid tube is used to collect waste fluid that is removed from the outlet tube of the hysteroscope.
Suzhou AcuVu medical technology Co., Ltd.
5.0mm×6.7mm×1000mm
In Commercial Distribution

  • 06974880990666 ()
  • 26974880990660 ()


  • Fluid transfer tube, general-purpose
SCALE, STAND-ON, PATIENT. A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Lark Technologies, Inc.
GBS-2104-G
In Commercial Distribution

  • 00860008199133 ()


  • Stand-on floor scale, electronic
Band-Lok® paste in syringe is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing syringe version. The adhesive is natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMBL
In Commercial Distribution

  • D798SMBL0 ()
SMBL

  • Dental composite resin
Band-Lok® paste in syringe is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing syringe version. The adhesive is natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
1SMBL
In Commercial Distribution

  • D7981SMBL0 ()
1SMBL

  • Dental composite resin
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB BELMONT 7M BIEN AIR
In Commercial Distribution

  • 03760278262100 ()
S_717_1508

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 SURG 1.5M
In Commercial Distribution

  • 03760278262087 ()
S_717_1506

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 2M GR3
In Commercial Distribution

  • 03760278262056 ()
S_717_1503

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 7M SF6
In Commercial Distribution

  • 03760278262049 ()
S_717_1502

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 2M SF6
In Commercial Distribution

  • 03760278262032 ()
S_717_1501

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB FEDESA 7M BIEN AIR
In Commercial Distribution

  • 03760278262094 ()
S_717_1507

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 7M GR3
In Commercial Distribution

  • 03760278262063 ()
S_717_1504

  • Diagnostic-imaging multiformat camera
Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable monitor (Screeni). Min. purchase is 5 pcs. = 1 box
AXESS VISION TECHNOLOGY
20030001
In Commercial Distribution

  • 03664977020033 ()
  • 03664977120030 ()

  • Lumen/Inner Diameter: 1.4 Millimeter
  • Outer Diameter: 3.9 Millimeter
  • Length: 605 Millimeter
20030001

  • Flexible video bronchoscope, single-use
Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (ormocers). Admira is suitable for restorations in both anterior and posterior teeth. This is a kit of 3 syringes.
VOCO GmbH
2431
In Commercial Distribution

  • E22124311 ()
2431

  • Dental composite resin
Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (ormocers). Admira is suitable for restorations in both anterior and posterior teeth. This is a kit of 7 syringes.
VOCO GmbH
2420
In Commercial Distribution

  • E22124201 ()
2420

  • Dental composite resin
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB BELMONT 7M BIEN AIR
In Commercial Distribution

  • M430S71715081 ()
S_717_1508

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB FEDESA 7M BIEN AIR
In Commercial Distribution

  • M430S71715071 ()
S_717_1507

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 SURG 1.5M
In Commercial Distribution

  • M430S71715061 ()
S_717_1506

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 7M GR3
In Commercial Distribution

  • M430S71715041 ()
S_717_1504

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 300 2M GR3
In Commercial Distribution

  • M430S71715031 ()
S_717_1503

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 7M SF6
In Commercial Distribution

  • M430S71715021 ()
S_717_1502

  • Diagnostic-imaging multiformat camera
"The DOCK U_USB2 module is built-in docking station for SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
DOCK U USB ADEC 500 2M SF6
In Commercial Distribution

  • M430S71715011 ()
S_717_1501

  • Diagnostic-imaging multiformat camera
The Clinisys Laboratory Solution (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
CliniSys, Inc
2023.3
In Commercial Distribution

  • B236CLS202330 ()


  • Clinical laboratory information system application software
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
CliniSys, Inc
2023.1.4
Not in Commercial Distribution

  • B236CLS20232140 ()


  • Clinical laboratory information system application software
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
CliniSys, Inc
2023.2
Not in Commercial Distribution

  • B236CLS2023200 ()


  • Clinical laboratory information system application software
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
CliniSys, Inc
2023.2
In Commercial Distribution

  • B236CLS202320 ()


  • Clinical laboratory information system application software
The Clinisys Laboratory Solutions (CLS) is a laboratory information management system that is used to manage laboratory work. The core platform is intended to be used by trained laboratory professionals.
CliniSys, Inc
2023.1
In Commercial Distribution

  • B236CLS202310 ()


  • Clinical laboratory information system application software
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3034
In Commercial Distribution

  • 10381780117339 ()
  • M268AH30341 ()

  • 1.339 in L x .121 in dia; .650 in thread
AH3034

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3028
In Commercial Distribution

  • 10381780117308 ()
  • M268AH30281 ()

  • 1.102 in L x .121 in dia; .530 in thread
AH3028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2510
In Commercial Distribution

  • 10381780117162 ()
  • M268AH25101 ()

  • .397 in L x .101 in dia; .170 in thread
AH2510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3032
In Commercial Distribution

  • 10381780117322 ()
  • M268AH30321 ()

  • 1.260 in L x .121 in dia; .610 in thread
AH3032

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3030
In Commercial Distribution

  • 10381780117315 ()
  • M268AH30301 ()

  • 1.181 in L x .121 in dia; .570 in thread
AH3030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3026
In Commercial Distribution

  • 10381780117292 ()
  • M268AH30261 ()

  • 1.024 in L x .121 in dia; .490 in thread
AH3026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3024
In Commercial Distribution

  • 10381780117285 ()
  • M268AH30241 ()

  • .945 in L x .121 in dia; .450 in thread
AH3024

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3022
In Commercial Distribution

  • 10381780117278 ()
  • M268AH30221 ()

  • .866 in L x .121 in dia; .410 in thread
AH3022

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3020
In Commercial Distribution

  • 10381780117261 ()
  • M268AH30201 ()

  • .787 in L x .121 in dia; .370 in thread
AH3020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3018
In Commercial Distribution

  • 10381780117254 ()
  • M268AH30181 ()

  • .709 in L x .121 in dia; .330 in thread
AH3018

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3016
In Commercial Distribution

  • 10381780117247 ()
  • M268AH30161 ()

  • .630 in L x .121 in dia; .290 in thread
AH3016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH3014
In Commercial Distribution

  • 10381780117230 ()
  • M268AH30141 ()

  • .551 in L x .121 in dia; .250 in thread
AH3014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2522
In Commercial Distribution

  • 10381780117223 ()
  • M268AH25221 ()

  • .866 in L x .101 in dia; .410 in thread
AH2522

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2520
In Commercial Distribution

  • 10381780117216 ()
  • M268AH25201 ()

  • .787 in L x .101 in dia; .370 in thread
AH2520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2518
In Commercial Distribution

  • 10381780117209 ()
  • M268AH25181 ()

  • .709 in L x .101 in dia; .330 in thread
AH2518

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2516
In Commercial Distribution

  • 10381780117193 ()
  • M268AH25161 ()

  • .630 in L x .101 in dia; .290 in thread
AH2516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture Headless screw is a cannulated, dual-thread, headless bone screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AH2514
In Commercial Distribution

  • 10381780117186 ()
  • M268AH25141 ()

  • .551 in L x .101 in dia; .250 in thread
AH2514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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