| Primary Device ID | 00840200409773 |
| NIH Device Record Key | 81be973a-950e-4c92-aea1-8e95621f927e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ASY-01139 |
| Catalog Number | ASY-01139 |
| 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 | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com | |
| Phone | 8002019300 |
| customerservice@integrityimplants.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840200409773 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
[00840200409773]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| 00840200409780 - NA | 2025-04-16 Adjustable Depth Stop, Tall, FH7 MIS2 |
| 00840200409797 - N/A | 2025-04-16 Short Cannula Body, FH7 MIS2 |
| 00840200409803 - N/A | 2025-04-16 Tall Cannula Body, FH7 MIS2 |
| 00840200409827 - NA | 2025-04-16 Dilator Handle, FH7 MIS2 |
| 00840200409858 - N/A | 2025-04-16 Articulating Curette, FH7 MIS2 |
| 00840200409872 - NA | 2025-04-16 7mm Open Shaver, FH7 MIS2 |
| 00840200409889 - NA | 2025-04-16 8mm Open Shaver, FH7 MIS2 |
| 00840200409896 - NA | 2025-04-16 9mm Open Shaver, FH7 MIS2 |