Identity
- Trade Name
- Ostene FDA UDI
- Generic Name
- Bone wax, synthetic FDA UDI
- Device Name
- Bone Hemostasis Material - 3.5g FDA UDI
- Model / Reference
- 1503831 FDA UDI
- Description
- Bone Hemostasis Material - 3.5g FDA UDI
Identifiers
- Catalog Number
- 1503831 FDA UDI
- Primary DI / UDI-DI
- 05413760467450 FDA UDI
- FDA Product Code
- MTJ FDA UDI
- GMDN Term
- Bone wax, synthetic FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 3.5 Gram FDA UDI
Category: Bone wax, synthetic
Ostene by Apatech Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- UNM Montage Flowable 8cc — ABYRX, INC. · U
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 U | Pending data |
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Manufacturer
- Manufacturer
- Apatech Ltd
Sources (1)
- FDA UDI 4cea82ed-8f5a-4be2-b586-b7cbabca8be1 37 fields · synced May 30, 2026