Primary Device ID | 00643169965102 |
NIH Device Record Key | 071d4e91-b5cb-4b47-a046-2378f660ef21 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GRAFTON PLUS™ DBM |
Version Model Number | T45005INT |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | true |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169965102 [Primary] |
MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-25 |
Device Publish Date | 2024-11-15 |
00763000855017 - n/a | 2025-06-06 INSTRUMENT 6248186 11X18X16 TRIAL |
00763000855215 - n/a | 2025-06-06 INSTRUMENT 6248864 8X16X14 TRIAL |
00763000889159 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120315 4.0 X 15 SELF TAP VAR |
00763000889166 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120314 4.0 X 14 SELF TAP VAR |
00763000889173 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120313 4.0 X 13 SELF TAP VAR |
00763000889227 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3125313 4.5 X 13 SELF TAP VAR |
00763000889319 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120214 4.0 X 14 SELF TAP FIX |
00763000889425 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120514 4.0 X 14 SELF DRILL VAR |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GRAFTON PLUS 76344860 2707900 Live/Registered |
Osteotech, Inc. 2001-12-04 |