Knotless Push-In Suture Anchor

GUDID 00816342024495

28 Knotless PEEK Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342024495
NIH Device Record Key513c92cb-c0be-4c80-a3c5-597ad85a2287
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnotless Push-In Suture Anchor
Version Model Number11321
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100816342024495 [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 Date2023-08-07
Device Publish Date2023-07-30

On-Brand Devices [Knotless Push-In Suture Anchor]

0081634202450128 Knotless PEEK Suture Anchor, Hip
0081634202449528 Knotless PEEK Suture Anchor
008163420241435.5 x 18.1mm, 55 Knotless, push-in, suture anchor, w/suture passer, PEEK CF
0081634202379535 Knotless Push-In Suture Anchor with Driver

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