| Primary Device ID | 03613720217510 |
| NIH Device Record Key | d7f738d9-076a-41eb-afaf-0e5ad19fbd5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMPIX-TLIF |
| Version Model Number | A15130607 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 03613720217510 [Primary] |
| HWT | Template |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
[03613720217510]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2017-02-01 |
| 03613720217503 | IMPIX-TLIF THREADED ROD v2 |
| 03613720217497 | IMPIX-TLIF HOLDER v2 |
| 03613720217442 | ANTI-ROTATION IMPIX-TLIF HOLDER |
| 03613720217435 | IMPIX-TLIF HOLDER STD |
| 03613720217428 | IMPIX-TLIF HOLDER STD THREADED ROD |
| 03613720217312 | IMPIX-TLIF HOLDER THREADED ROD |
| 03613720217305 | IMPIX-TLIF HOLDER |
| 03613720267102 | IMPIX-TLIF LUMBAR CAGE 17mm - 6° |
| 03613720217534 | TRIAL FOR IMPIX-TLIF 11mm - 6° |
| 03613720217480 | STRAIGHT HANDLE WITH HAMMERING PLATE |
| 03613720217374 | LEFT VALVE FOR LAMINA |
| 03613720217367 | TLIF DISTRACTOR |
| 03613720217350 | RIGHT VALVE ON SCREWS |
| 03613720217558 | TRIAL FOR IMPIX-TLIF 15mm - 6° |
| 03613720217541 | TRIAL FOR IMPIX-TLIF 13mm - 6° |
| 03613720217527 | TRIAL FOR IMPIX-TLIF 9mm - 6° |
| 03613720217510 | TRIAL FOR IMPIX-TLIF 7mm - 6° |
| 03613720217466 | LARGE VALVE RETRACTOR |
| 03613720217459 | SMALL VALVE RETRACTOR |
| 03613720217404 | SUPPORT LID |
| 03613720217398 | STRAIGHT HANDLE WITH HAMMERING PLATE |
| 03613720217381 | RIGHT VALVE FOR LAMINA |
| 03613720217343 | LEFT VALVE ON SCREWS |
| 03613720217336 | IMPIX-TLIF GRAFT COMPACTOR |
| 03613720217329 | IMPIX-TLIF SUPPORT |
| 03613720217299 | IMPIX-TLIF INSTRUMENT CASE |