| Primary Device ID | 00810045534572 |
| NIH Device Record Key | 9aea4f50-7212-4eaa-be07-5790f829ee40 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ASY-00720 |
| Catalog Number | ASY-00720 |
| 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 | 00810045534572 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
[00810045534572]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-13 |
| Device Publish Date | 2021-01-05 |
| 00840200405492 - NA | 2024-09-09 BH Tapered Screw Starter |
| 00840200410045 - N/A | 2024-07-18 SS Right Blade, 80mm |
| 00840200410052 - N/A | 2024-07-18 SS Right Blade, 70mm |
| 00840200410069 - N/A | 2024-07-18 SS Right Blade, 60mm |
| 00840200410076 - N/A | 2024-07-18 SS Right Blade, 50mm |
| 00840200410083 - N/A | 2024-07-18 SS Left Blade, 80mm |
| 00840200410090 - N/A | 2024-07-18 SS Left Blade, 70mm |
| 00840200410106 - N/A | 2024-07-18 SS Left Blade, 60mm |