| Primary Device ID | 00817337000319 |
| NIH Device Record Key | 2b3632fb-ca37-4394-a4c9-aed284343421 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Deployment Skid Cannula Access Tool |
| Version Model Number | 6000128 |
| Company DUNS | 807613393 |
| Company Name | Anika Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 00817337000319 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
[00817337000319]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-23 |
| Device Publish Date | 2024-05-15 |
| 00817337000425 - Integrity Implant | 2025-09-29 Integrity Implant, 40mm x 60mm |
| 08033549790738 - Epifilm Otologic | 2025-06-12 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 |
| 08033549790745 - Epidisc 2pk Otologic 8mm | 2025-06-12 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 Kit | 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. |
| 08033549790769 - Merogel Injectable | 2025-06-12 MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to c |
| 08033549790974 - Epifilm Otologic | 2025-06-12 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 8mm | 2025-06-12 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 Kit | 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. |