Primary Device ID | 03613720217312 |
NIH Device Record Key | 1d2a6326-7eda-48cb-ad8a-cdf8937c75ec |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMPIX-TLIF |
Version Model Number | A15130003 |
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 | 03613720217312 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
[03613720217312]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2019-04-23 |
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 |