Primary Device ID | 00763000152628 |
NIH Device Record Key | b799a31d-5f7b-4608-97ba-7bac586ca9d1 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 7068031 |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000152628 [Primary] |
KCT | Sterilization wrap containers, trays, cassettes & other accessories |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
[00763000152628]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-14 |
Device Publish Date | 2020-02-06 |
00763000663865 - n/a | 2025-07-28 DRILL BIT 7080513 STERILE 13MM |
00763000856472 - Pyramesh® Implant System | 2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM |
00763000856489 - Pyramesh® Implant System | 2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM |
00763000856502 - Pyramesh® Implant System | 2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM |
00763000856519 - Pyramesh® Implant System | 2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM |
00763000856526 - Pyramesh® Implant System | 2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM |
00763000856533 - Pyramesh® Implant System | 2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM |
00763000856557 - Pyramesh® Implant System | 2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM |