GFS

GUDID 00816342022514

GFS Ultimate Large

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342022514
NIH Device Record Key6de6cc34-4d66-4f45-82dd-5b41bcf8b488
Commercial Distribution StatusIn Commercial Distribution
Brand NameGFS
Version Model Number10974
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342022514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-04
Device Publish Date2023-07-27

On-Brand Devices [GFS]

00816342021968GFS II XLG Naked
00816342021951GFS II LG Naked
00816342021944GFS II Std Naked
00816342021937GFS Mini Naked
00816342021920GFS Micro Naked
00816342021913GFS Nano Naked
00816342021906GFS Mini 60mm Loop
00816342021890GFS Mini 55mm Loop
00816342021883GFS Mini 50mm Loop
00816342021876GFS Mini 45mm Loop
00816342021869GFS Mini 40mm Loop
00816342021852GFS Mini 35mm Loop
00816342021845GFS Mini 30mm Loop
00816342021838GFS Mini 25mm Loop
00816342021821GFS Mini 20mm Loop
00816342021814GFS Mini 15mm Loop
00816342021807GFS Mini 12mm Loop
00816342021791GFS II Large 60mm Loop
00816342021784GFS II Large 55mm Loop
00816342021777GFS II Large 50mm Loop
00816342021760GFS II Large 45mm Loop
00816342021753GFS II Large 40mm Loop
00816342021746GFS II Large 35mm Loop
00816342021739GFS II Large 30mm Loop
00816342021722GFS II Large 25mm Loop
00816342021715GFS II Large 20mm Loop
00816342021708GFS II Large 15mm Loop
00816342025164GFS Ultimate Micro
00816342024976GFS BTB Link
00816342024518GFS Ultimate Hip
00816342022514GFS Ultimate Large
00816342022507GFS Ultimate Mini
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