V-LoX3 10284T

GUDID M68510284T0

5.5mm V-LoX3 Titanium Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device IDM68510284T0
NIH Device Record Key5fb9652f-ab94-4ebd-9f30-6c9b99724a64
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-LoX3
Version Model Number10284T
Catalog Number10284T
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Dimensions

Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68510284T0 [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 Date2019-06-28
Device Publish Date2019-06-20

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M68510284T05.5mm V-LoX3 Titanium Suture Anchor

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