Primary Device ID | 00889024223769 |
NIH Device Record Key | f8eb2161-f4a4-4476-bb3f-ee8a9f20f5c0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TM Ardis® |
Version Model Number | 96-701-02071 |
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 | 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 |
Phone | +1(800)348-2759 |
zimmer.consumerrelations@zimmer.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00889024223769 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00889024223769]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-02-07 |
Device Publish Date | 2016-05-26 |
00889024320635 | 96-701-30001 |
00889024320628 | 96-701-21161 |
00889024320611 | 96-701-21121 |
00889024320604 | 96-701-21101 |
00889024320598 | 96-701-21081 |
00889024320581 | 96-701-20161 |
00889024320574 | 96-701-20121 |
00889024320567 | 96-701-20101 |
00889024320550 | 96-701-20081 |
00889024320543 | 96-701-10001 |
00889024223813 | 96-701-31001 |
00889024223806 | 96-701-06071 |
00889024223790 | 96-701-05071 |
00889024223783 | 96-701-04071 |
00889024223776 | 96-701-03071 |
00889024223769 | 96-701-02071 |
00889024223752 | 96-701-01071 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TM ARDIS 85541803 4354906 Live/Registered |
Zimmer Biomet Spine, Inc. 2012-02-14 |