Primary Device ID | M06760001020 |
NIH Device Record Key | 0d4d1512-962a-49e4-be4e-5ed645f3b8fd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integrity Implant Fixation Kit |
Version Model Number | 6000102 |
Company DUNS | 807613393 |
Company Name | Anika Therapeutics, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M06760001020 [Primary] |
MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-22 |
Device Publish Date | 2023-11-14 |
M06760001020 - Integrity Implant Fixation Kit | 2023-11-22Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy. |
M06760001020 - Integrity Implant Fixation Kit | 2023-11-22 Integrity Tissue Tacks and Integrity Bone Staples packaged in a Caddy. |
M06760001180 - Integrity Delivery Instrument, Bone Staple | 2023-11-22 Integrity bone staple delivery instrument, single-use |
M06760001200 - Integrity Delivery Instrument, Tissue Tack | 2023-11-22 Integrity tissue tack delivery instrument, single use |
00817337000241 - Integrity Implant | 2023-11-17 Integrity Implant, 20mm x 25mm |
00817337000258 - Integrity Implant | 2023-11-17 Integrity Implant, 25mmx30mm |
M06760001220 - Integrity Cannula/Obturator Kit | 2023-11-17 Integrity Cannula and Obturator, single-use |
08033549791063 - Epifilm Otologic | 2022-02-14 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 |
00817337000128 - Ophthalin | 2022-01-06 0.8 ml, 1.2% OVD Sodium Hyaluronate |