| Primary Device ID | 00810004729117 |
| NIH Device Record Key | 2ba0f619-2af3-4495-9991-018a4335eb2c |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ASY-00520 |
| Catalog Number | ASY-00520 |
| Company DUNS | 080300717 |
| Company Name | INTEGRITY IMPLANTS 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 | false |
| 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 | 00810004729117 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
[00810004729117]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 00840200410656 - NA | 2025-07-25 Lock Check Handle, FH9 |
| 00810045530307 - FlareHawk | 2025-07-11 Shell, Short 25 mm, FH9 Sterile |
| 00810045530314 - FlareHawk | 2025-07-11 Shell, Tall 25 mm, FH9 Sterile |
| 00810045530321 - FlareHawk | 2025-07-11 Shell, Lordotic 25 mm, FH9 Sterile |
| 00810045530338 - FlareHawk | 2025-07-11 Shell, Short 29 mm, FH9 Sterile |
| 00810045530345 - FlareHawk | 2025-07-11 Shell, Tall 29 mm, FH9 Sterile |
| 00810045530352 - FlareHawk | 2025-07-11 Shell, Lordotic 29 mm, FH9 Sterile |
| 00810045530567 - FlareHawk | 2025-07-11 Shell, Short 26mm, FH7 Sterile |