Identity
- Trade Name
- GRAFTON PLUS™ DBM FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- DBM T45005INT 5CC PASTE GRAFTON PLUS FDA UDI
- Model / Reference
- T45005INT FDA UDI
- Description
- DBM T45005INT 5CC PASTE GRAFTON PLUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169965102 FDA UDI
- FDA Product Code
- MBP FDA UDI
- GMDN Term
- Bone matrix implant, human-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Bone matrix implant, human-derived
Grafton Plus™ Dbm by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone matrix implant, human-derived.
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Cleared under the same submission
K042707 also covers:
K043048 also covers:
- GRAFTON PLUS® DBM — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON PLUS® DBM — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON PLUS® DBM — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON PLUS® DBM — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON® DBM — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC.
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 071d4e91-b5cb-4b47-a046-2378f660ef21 35 fields · synced Jun 6, 2026