Primary Device ID | 00763000139988 |
NIH Device Record Key | 4bd8c82f-6713-4f7b-9c58-ccda6ac76292 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 9564001 |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000139988 [Primary] |
GAD | RETRACTOR |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00763000139988]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-21 |
Device Publish Date | 2019-06-13 |
00763000764050 - OsteoCool™ 2.0 RF Ablation System | 2024-11-19 CART OCA01-100 OC 2.0 100W STAND |
00763000670542 - n/a | 2024-11-18 TEMPLATE 3005975 ZEVO 75MM 5 LVL |
00763000670559 - n/a | 2024-11-18 TEMPLATE 3005977 ZEVO 77MM 5 LVL |
00763000670566 - n/a | 2024-11-18 TEMPLATE 3005979 ZEVO 79MM 5 LVL |
00763000670573 - n/a | 2024-11-18 TEMPLATE 3005981 ZEVO 81MM 5 LVL |
00763000670580 - n/a | 2024-11-18 TEMPLATE 3005985 ZEVO 85MM 5 LVL |
00763000670597 - n/a | 2024-11-18 TEMPLATE 3005990 ZEVO 90MM 5 LVL |
00763000670603 - n/a | 2024-11-18 TEMPLATE 3005995 ZEVO 95MM 5 LVL |