Identity
- Trade Name
- PuraXen+ FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 2.0g FDA UDI
- Model / Reference
- XEN-1000-200 FDA UDI
- Description
- PuraXen+ Anorganic Cancellous Particulate (1.0-2.0mm) - 2.0g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852072007612 FDA UDI
- 510(k) Number
- K151209 FDA UDI
- FDA Product Code
- NPM FDA UDI
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bone matrix implant, animal-derived
PuraXen+ by Sigmagraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental bone matrix implant, animal-derived.
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Cleared under the same submission
K151209 also covers:
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THE
- DirectOss™ — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- DirectOss™ — IMPLANT DIRECT SYBRON MANUFACTURING LLC
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
- Sigmagraft, Inc.
Sources (1)
- FDA UDI 318eff6a-345f-485a-ad15-d9ab85cc6c0f 34 fields · synced May 30, 2026