Identity
- Trade Name
- nanOss Strata Strip 50x25x8mm FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- nanOss Strata Strip 50x25x8mm FDA UDI
- Model / Reference
- 450508 FDA UDI
- Description
- nanOss Strata Strip 50x25x8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812593022075 FDA UDI
- 510(k) Number
- K193487 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Synthetic bone graft
nanOss Strata Strip 50x25x8mm by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193487 also covers:
- Agilon — Biogennix, LLC
- Agilon — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- DirectCell Advanced Bone Grafting System — Biogennix, LLC
- DirectCell Advanced Bone Grafting System — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, 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
- Biogennix, LLC
Sources (1)
- FDA UDI acec9e8b-806a-4ab0-a8f9-e7191bdf47de 34 fields · synced Jun 1, 2026