Identity
- Trade Name
- PRO-STIM FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- Injectable FDA UDI
- Model / Reference
- 86SR0404 FDA UDI
- Description
- Injectable FDA UDI
Identifiers
- Catalog Number
- 86SR0404 FDA UDI
- Primary DI / UDI-DI
- 00840420143136 FDA UDI
- FDA Product Code
- MBP FDA UDIMQV 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 4 Milliliter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobialBone matrix implant, human-derived
Pro-Stim by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, human-derived.
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- InterGro DBM Paste — Biomet Orthopedics, Inc. · Class II
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Trel-X Putty — Integra Lifesciences Corp. · Class II
- Puros® — ZIMMER SPINE, INC. · Class II
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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI cd89a732-f6fb-4111-a734-5a7db7e753f5 37 fields · synced Jun 8, 2026