Biocomposite Suture Anchors

GUDID 00816342024808

28 Knotless AP Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID00816342024808
NIH Device Record Keybec371fd-3e83-4c55-89f9-81866f1f45c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiocomposite Suture Anchors
Version Model Number10802
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
GS100816342024808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, 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 [Biocomposite Suture Anchors]

008163420252324.5mm Twist Biocomposite SST Suture Anchor
008163420252254.5mm Twist Biocomposite SST Suture Anchor
008163420251574.5mm Twist Biocomposite Suture Anchor
0081634202482255 Knotless AP Suture Anchor
0081634202481545 Knotless AP Suture Anchor
0081634202480828 Knotless AP Suture Anchor

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