| Primary Device ID | 00840200409353 |
| NIH Device Record Key | 96cd338a-65dc-4be5-9241-647b0e0acc76 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ASY-01096 |
| Catalog Number | ASY-01096 |
| 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 |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com | |
| Phone | 800.201.9300 |
| customerservice@integrityimplants.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840200409353 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
[00840200409353]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-10 |
| Device Publish Date | 2022-11-02 |
| 00840200410229 - NA | 2024-10-28 5.5-6.0 MIS Counter Torque - No Lip |
| 00840200402477 - LineSider | 2024-10-25 5.5/6.0mm, Non-mod Standard 7.1mm- Iliac Shank - 9.5mm x 90mm |
| 00840200407373 - N/A | 2024-10-25 Open Disc Prep Insert 2 |
| 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 |