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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The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830050
In Commercial Distribution

  • 10381780118534 ()
  • M26828300501 ()

  • 50 mm L x 3.5 mm dia
2830050

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830045
In Commercial Distribution

  • 10381780118527 ()
  • M26828300451 ()

  • 45 mm L x 3.5 mm dia
2830045

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830040
In Commercial Distribution

  • 10381780118510 ()
  • M26828300401 ()

  • 40 mm L x 3.5 mm dia
2830040

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830035
In Commercial Distribution

  • 10381780118503 ()
  • M26828300351 ()

  • 35 mm L x 3.5 mm dia
2830035

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830032
In Commercial Distribution

  • 10381780118497 ()
  • M26828300321 ()

  • 32 mm L x 3.5 mm dia
2830032

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830030
In Commercial Distribution

  • 10381780118480 ()
  • M26828300301 ()

  • 30 mm L x 3.5 mm dia
2830030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830028
In Commercial Distribution

  • 10381780118473 ()
  • M26828300281 ()

  • 28 mm L x 3.5 mm dia
2830028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830026
In Commercial Distribution

  • 10381780118466 ()
  • M26828300261 ()

  • 26 mm L x 3.5 mm dia
2830026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830024
In Commercial Distribution

  • 10381780118459 ()
  • M26828300241 ()

  • 24 mm L x 3.5 mm dia
2830024

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830022
In Commercial Distribution

  • 10381780118442 ()
  • M26828300221 ()

  • 22 mm L x 3.5 mm dia
2830022

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830020
In Commercial Distribution

  • 10381780118435 ()
  • M26828300201 ()

  • 20 mm L x 3.5 mm dia
2830020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830018
In Commercial Distribution

  • 10381780118428 ()
  • M26828300181 ()

  • 18 mm L x 3.5 mm dia
2830018

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830016
In Commercial Distribution

  • 10381780118411 ()
  • M26828300161 ()

  • 16 mm L x 3.5 mm dia
2830016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830014
In Commercial Distribution

  • 10381780118404 ()
  • M26828300141 ()

  • 14 mm L x 3.5 mm dia
2830014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking rearfoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2830012
In Commercial Distribution

  • 10381780118398 ()
  • M26828300121 ()

  • 12 mm L x 3.5 mm dia
2830012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
Ascension Orthopedics, Inc.
2835010
In Commercial Distribution

  • 10381780118701 ()
  • M26828350101 ()

  • 10 mm L x 2.7 mm dia
2835010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The nut is made from stainless steel and is used to secure the strut into the ring.
Ascension Orthopedics, Inc.
12224255
In Commercial Distribution

  • 10381780125266 ()

  • 10 mm hex x 5 mm H
12224255

  • External orthopaedic fixation system, reusable
The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.
NORTH EAST SCIENTIFIC INC
R-RFS2-6-12
Not in Commercial Distribution

  • B227RRFS2612 ()
R-RFS2-6-12

  • Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
The SURFIX® compressor is used for closing the resected angle when a closing osteotomy is implemented
NEWDEAL
MA043ND
In Commercial Distribution

  • M248MA043ND1 ()
  • 10381780044666 ()


  • Surgical flat-nosed pliers
Raypilot Transmitter Tester is to test the function of the transmitter, which is included in Raypilot Hypocath.
Micropos Medical AB (Publ)
1
In Commercial Distribution

  • 07350007954060 ()
4006

  • Radiation therapy invasive marker lesion localization system
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Vascular Solutions, Inc.
8181
Not in Commercial Distribution

  • M20681810 ()
  • M20681811 ()


  • Torque manipulation device
SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp
Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials.
IMMUCOR, INC.
0057292
In Commercial Distribution

  • 10888234000990 ()
0057292

  • Papain immunohaematology reagent IVD
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade. This is a NonFluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
NFBLSA
In Commercial Distribution

  • D798NFBLSA0 ()
NFBLSA

  • Orthodontic bracket adhesive
The basis is part of the container which product number is 519950ND and that is used for transport and sterilization of the Panta® Nail Removal Kit.
NEWDEAL
519951ND
Not in Commercial Distribution

  • M248519951ND1 ()
  • 10381780042792 ()


  • Device sterilization/disinfection container, reusable
The tray base is part of the container which product number is 339900ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
339910ND
Not in Commercial Distribution

  • M248339910ND1 ()
  • 10381780042693 ()


  • Device sterilization/disinfection container, reusable
The upper basis is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299911ND
Not in Commercial Distribution

  • M248299911ND1 ()
  • 10381780042471 ()


  • Device sterilization/disinfection container, reusable
The screw rack is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
188216ND
Not in Commercial Distribution

  • M248188216ND1 ()
  • 10381780042372 ()


  • Device sterilization/disinfection container, reusable
BEAR™ mini is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ mini is a smart microcurrent facial toning device.
Foreo AB
PEARL PINK
In Commercial Distribution

  • 07350092139526 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
BEAR™ mini is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ mini is a smart microcurrent facial toning device.
Foreo AB
LAVENDER
In Commercial Distribution

  • 07350092139519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box.
IMMUCOR, INC.
0005070
In Commercial Distribution

  • 10888234000501 ()
0005070

  • pH-adjusted buffer solution IVD
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0015
In Commercial Distribution

  • 04715309122051 ()
  • 04715309125021 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0016
In Commercial Distribution

  • 04715309122068 ()
  • 04715309125014 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
BA8200
In Commercial Distribution

  • 04715309122938 ()
  • 04715309125243 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0014
In Commercial Distribution

  • 04715309122044 ()
  • 04715309124987 ()


  • Endometrial biopsy kit
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
HD-15A
In Commercial Distribution

  • 00850035134887 ()


  • Cosmetic red-light phototherapy system, home-use
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in ten-hole.
Ascension Orthopedics, Inc.
HFP0930310LS
In Commercial Distribution

  • 10381780120834 ()
  • M268HFP0930310LS1 ()

  • 5.450 mm L
HFP0930310LS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in ten-hole.
Ascension Orthopedics, Inc.
HFP0930310RS
In Commercial Distribution

  • 10381780120827 ()
  • M268HFP0930310RS1 ()

  • 5.450 mm L
HFP0930310RS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in seven-hole.
Ascension Orthopedics, Inc.
HFP0930307LS
In Commercial Distribution

  • 10381780120810 ()
  • M268HFP0930307LS1 ()

  • 4.512 mm L
HFP0930307LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in seven-hole.
Ascension Orthopedics, Inc.
HFP0930307RS
In Commercial Distribution

  • 10381780120803 ()
  • M268HFP0930307RS1 ()

  • 4.512 mm L
HFP0930307RS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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