| 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 |
| 00817337000319 - Deployment Skid Cannula Access Tool | 2024-05-23 Reusable non-rigid cannula access tool |
| 08033549791117 - MEROGEL 2pk 4x4cm | 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat |
| 08033549791124 - MEROGEL 1PK 4x4cm | 2024-04-26 Merogel is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separat |
| 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 |