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 |
00763000273804 - n/a | 2025-10-06 SCREWDRIVER 3606201 TORQUE LIMIT SHAFT |
00763000875282 - SHILLA™ Growth Guidance System | 2025-10-06 SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30 |
00763000884956 - n/a | 2025-10-06 LOCK SCREW DRIVER 7080930 TRI-FLAT |
00885074240695 - n/a | 2025-09-30 ACCESSORIES 3299003 GRAFT TAMP |
00199150026029 - Medtronic Reusable Instruments | 2025-09-29 COMPRESSOR X0525001 RACK AND PINION |
00763000684044 - Medtronic Reusable Instruments | 2025-09-29 INSTRUMENT 950-146 RULER |
00763000856700 - VERTE-STACK® Spinal System | 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM |
00763000879563 - ENDOSKELETON® TCS | 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GRAFTON PLUS 76344860 2707900 Live/Registered |
Osteotech, Inc. 2001-12-04 |