Integrity Implant Fixation Kit

GUDID M06760001020

Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy.

Anika Therapeutics, Inc.

Soft-tissue/mesh anchor, bioabsorbable
Primary Device IDM06760001020
NIH Device Record Key0d4d1512-962a-49e4-be4e-5ed645f3b8fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrity Implant Fixation Kit
Version Model Number6000102
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
HIBCCM06760001020 [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 Date2023-11-22
Device Publish Date2023-11-14

Devices Manufactured by Anika Therapeutics, Inc.

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08033549790745 - Epidisc 2pk Otologic 8mm2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin
08033549790752 - EpiDisc TM Perf Patch Kit2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
08033549790769 - Merogel Injectable2025-06-12 MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to c
08033549790974 - Epifilm Otologic2025-06-12 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na
08033549790981 - Epidisc 2pk Otologic 8mm2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin
08033549790998 - EpiDisc TM Perf Patch Kit2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
00817337000319 - Deployment Skid Cannula Access Tool2024-05-23 Reusable non-rigid cannula access tool

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