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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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Band Lok - D798SMBL0

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

Broncoflex Agile - 03664977020033

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

ACTEON - 03760278262100

"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

ACTEON - 03760278262094

"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

ACTEON - 03760278262087

"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

ACTEON - 03760278262063

"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

ACTEON - 03760278262056

"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

ACTEON - 03760278262049

"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

ACTEON - 03760278262032

"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

ACTEON - M430S71715081

"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

ACTEON - M430S71715071

"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

ACTEON - M430S71715061

"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

ACTEON - M430S71715041

"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

ACTEON - M430S71715031

"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

ACTEON - M430S71715021

"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

ACTEON - M430S71715011

"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

Clinisys Laboratory Solution - B236CLS202330

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

Clinisys Laboratory Solutions - B236CLS20232140

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

Clinisys Laboratory Solutions - B236CLS2023200

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

Clinisys Laboratory Solutions - B236CLS202320

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

Clinisys Laboratory Solutions - B236CLS202310

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

Admira - E22124311

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 - E22124201

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

CAPTURE™ Screw System - 10381780117322

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

CAPTURE™ Screw System - 10381780117308

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

CAPTURE™ Screw System - 10381780117285

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

CAPTURE™ Screw System - 10381780117261

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

CAPTURE™ Screw System - 10381780117247

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

CAPTURE™ Screw System - 10381780117223

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

CAPTURE™ Screw System - 10381780117209

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
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