Primary Device ID | 00810004729841 |
NIH Device Record Key | 64d7c93d-7418-4331-a409-e3817b517f6a |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | ASY-00577 |
Catalog Number | ASY-00577 |
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 | true |
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 | |
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 | 00810004729841 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
[00810004729841]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-11 |
Device Publish Date | 2022-10-03 |
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 |
00840200410113 - N/A | 2024-07-18 SS Left Blade, 50mm |