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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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Curved Adjustable Gastric Band with Sutureless Port and Applier
Obtech Medical Sàrl
RLZB32
Not in Commercial Distribution

  • 30705036004008 ()
  • 20705036004001 ()
RLZB32

  • Gastric band
LAP-BAND® AP Adjustable Gastric Banding System Large with RapidPort EZ
ReShape Lifesciences Inc.
C-2365
In Commercial Distribution


  • Large
C-2365

  • Gastric band
LAP-BAND® AP Adjustable Gastric Banding System Standard with RapidPort EZ
ReShape Lifesciences Inc.
C-2360
In Commercial Distribution


  • Standard
C-2360

  • Gastric band
ReShape Lap-Band® 2.0 FLEX, Large
ReShape Lifesciences Inc.
D-3365
In Commercial Distribution

  • 00850007764517 ()

  • Large
D-3365

  • Gastric band
ReShape Lap-Band® 2.0 FLEX, Standard
ReShape Lifesciences Inc.
D-3360
In Commercial Distribution

  • 00850007764500 ()

  • Standard
D-3360

  • Gastric band
GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® absorbable gelatin powder, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
BAXTER HEALTHCARE CORPORATION
1503188
Not in Commercial Distribution

  • 50085412095160 ()
  • 00085412095165 ()
1503188

  • Collagen haemostatic agent, non-antimicrobial
GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Compressed Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
BAXTER HEALTHCARE CORPORATION
1503187
Not in Commercial Distribution

  • 50085412095153 ()
  • 00085412095158 ()
1503187

  • Collagen haemostatic agent, non-antimicrobial
Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, battery operated device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
HYPERBRANCH MEDICAL TECHNOLOGY, INC.
NUS-109
In Commercial Distribution

  • 30897146002026 ()
  • 00897146002025 ()


  • Dura mater sealant
No Description
Biomet Orthopedics, LLC
178574
In Commercial Distribution

  • 00880304461789 ()
  • 70880304461788 ()

  • 76MM LENGTH
178574

  • Orthopaedic bone pin, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
178573
In Commercial Distribution

  • 00880304461772 ()
  • 70880304461771 ()

  • 72MM LENGTH
178573

  • Orthopaedic bone pin, non-bioabsorbable
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