Primary Device ID | 00889024316119 |
NIH Device Record Key | ec6f843b-6631-4ebf-95ed-5048fa97f746 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TM Ardis® Trabecular Metal™ |
Version Model Number | 06-701-06131 |
Company DUNS | 793120965 |
Company Name | ZIMMER TRABECULAR METAL TECHNOLOGY INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
Phone | +1(800)348-2759 |
zimmer.consumerrelations@zimmer.com | |
Phone | +1(800)348-2759 |
zimmer.consumerrelations@zimmerbiomet.com |
Height | 13 Millimeter |
Height | 13 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00889024316119 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2015-09-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TM ARDIS 85541803 4354906 Live/Registered |
Zimmer Biomet Spine, Inc. 2012-02-14 |