| Primary Device ID | 00810004728363 |
| NIH Device Record Key | 34827e0a-a813-4c2e-8c29-e84e6585d03e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | ASY-00415 |
| Catalog Number | ASY-00415 |
| 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 | 00810004728363 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
[00810004728363]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-25 |
| Device Publish Date | 2020-05-15 |
| 00840200409759 - N/A | 2024-04-01 COMPRESSOR - COUNTER TORQUE ATTACHMENT |
| 00840200409537 - LineSider | 2024-03-12 MIS Fixed Rod Inserter |
| 00840200409667 - LineSider | 2024-03-12 MIS Rod Inserter Locking Shaft |
| 00840200409735 - LineSider | 2024-03-12 MIS Fixed Rod Inserter, Winged |
| 00840200408790 - N/A | 2024-02-14 Vertebral Body Spreader |
| 00840200408806 - N/A | 2024-02-14 Finger Pad, Right |
| 00840200408813 - N/A | 2024-02-14 Finger Pad, Left |
| 00840200409339 - N/A | 2024-02-07 1.5mm KIRSCHNER WIRE XL, 316SS, THREADED, TROCAR TIP |