Twist Knotless

GUDID 00816342024037

4.75 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342024037
NIH Device Record Key440f6772-12e4-408d-afde-43d55200a6a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwist Knotless
Version Model Number11259
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
GS100816342024037 [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 Date2023-07-29

On-Brand Devices [Twist Knotless]

M6851116706.25 x 15 Twist Knotless PEEK Suture Anchor
M6851116605.5 x 15 Twist Knotless PEEK Suture Anchor
M6851116504.75 x 15 Twist Knotless PEEK Suture Anchor
008163420240135.5 x 15 Twist Knotless PEEK Suture Anchor
008163420240516.25 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
008163420240445.5 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
008163420240374.75 x 15mm, Twist, knotless, DEX, screw-in, suture anchor, w/suture threader, PEEK
008163420240206.25 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK
008163420240064.75 x 15mm, Twist, knotless, screw-in, suture anchor, w/suture threader, PEEK

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