Actiflip

GUDID 00816342023979

3.9 x 12mm AcTiFlip, w/1 infinity loop (wht/blu), w/needle, w/suture threader

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342023979
NIH Device Record Key0581d1c5-8bb6-49c5-944b-a53b407ba88e
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiflip
Version Model Number11185
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100816342023979 [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 [Actiflip]

00816342024952Actiflip Cinch #2 w/ Needles
M68511185SB0Actiflip w/ #2 Infinity Loop
00816342024969Actiflip w/ #2 Infinity Loop
008163420239793.9 x 12mm AcTiFlip, w/1 infinity loop (wht/blu), w/needle, w/suture threader
00816342023962AcTiFlip Cinch #2 w/ Needles

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.