Slik Fix Screw

GUDID 00816342023474

8.0 x 15 SLiK Fix PEEK CF Screw

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342023474
NIH Device Record Keyeb1b97fb-1244-4b04-8e67-430253ac12c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlik Fix Screw
Version Model Number10996
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
GS100816342023474 [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 [Slik Fix Screw]

008163420234817.0 x 15 SLiK Fix PEEK CF Screw
008163420234748.0 x 15 SLiK Fix PEEK CF Screw
008163420234679.0 x 15 SLiK Fix PEEK CF Screw
008163420234509.0 x 15 SLiK Fix PEEK Screw
008163420234438.0 x 15 SLiK Fix PEEK Screw
008163420234367.0 x 15 SLiK Fix PEEK Screw

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