SnugFit All-Suture Anchor

GUDID 07630345712745

SnugFit All-Suture anchor Size 1 – Long – 1x USP#2

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID07630345712745
NIH Device Record Key7574518e-c99e-424f-bee8-92e3c4d1ad37
Commercial Distribution StatusIn Commercial Distribution
Brand NameSnugFit All-Suture Anchor
Version Model Number05.11.022
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
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
GS107630345712745 [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 Date2021-01-29
Device Publish Date2021-01-21

On-Brand Devices [SnugFit All-Suture Anchor]

07630345717184SnugFit All-Suture anchor Size 2 – Short – 2x USP#2 / 1x Tape
07630345714060SnugFit All-Suture anchor Size 2 – Short – 3x USP#2
07630345712769SnugFit All-Suture anchor Size 2 – Short – 1x USP#2 / 1x Tape
07630345712752SnugFit All-Suture anchor Size 2 – Short – 2x USP#2
07630345712745SnugFit All-Suture anchor Size 1 – Long – 1x USP#2
07630345712738SnugFit All-Suture anchor Size 1 – Short – 1x USP#2
07630345780140SnugFit All-Suture anchor Size 1 - Ø1.8 – Long– 1x USP#2
07630345780133SnugFit All-Suture anchor Size 1 - Ø1.8 – Short – 1x USP#2

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