Primary Device ID | 00643169838000 |
NIH Device Record Key | d5d79b5e-4aa6-4a1a-b31b-d6f1425e76a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARTiC-XL™ Spinal System |
Version Model Number | 54301825 |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, 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)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169838000 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00643169838000]
Moist Heat or Steam Sterilization
[00643169838000]
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 | 2017-10-27 |
00643169838123 | TRIAL 54501835 L 50 HT 18 DEG 35 |
00643169838116 | TRIAL 54501535 L 50 HT 15 DEG 35 |
00643169838109 | TRIAL 54501825 L 50 HT 18 DEG 25 |
00643169838093 | TRIAL 54501525 L 50 HT 15 DEG 25 |
00643169838086 | TRIAL 54501225 L 50 HT 12 DEG 25 |
00643169838079 | TRIAL 54401835 L 40 HT 18 DEG 35 |
00643169838062 | TRIAL 54401535 L 40 HT 15 DEG 35 |
00643169838055 | TRIAL 54401825 L 40 HT 18 DEG 25 |
00643169838048 | TRIAL 54401525 L 40 HT 15 DEG 25 |
00643169838031 | TRIAL 54401225 L 40 HT 12 DEG 25 |
00643169838024 | TRIAL 54301835 L 30 HT 18 DEG 35 |
00643169838000 | TRIAL 54301825 L 30 HT 18 DEG 25 |
00643169837997 | TRIAL 54301525 L 30 HT 15 DEG 25 |
00643169837980 | TRIAL 54301225 L 30 HT 12 DEG 25 |
00643169838017 | TRIAL 54301535 L 30 HT 15 DEG 35 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ARTIC-XL 87303941 not registered Live/Pending |
Warsaw Orthopedic, Inc. 2017-01-17 |