Identity
- Trade Name
- Hemasorb 2.0 gram with Spatula FDA UDI
- Generic Name
- Bone wax, synthetic FDA UDI
- Device Name
- Product Box also contains OS-SPA DI 00850391007146 FDA UDI
- Model / Reference
- OS-201 FDA UDI
- Description
- Product Box also contains OS-SPA DI 00850391007146 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850391007023 FDA UDI
- 510(k) Number
- K043260 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Bone wax, synthetic
Hemasorb 2.0 gram with Spatula by Abyrx, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone wax, synthetic.
- BoneSeal 2.5 gram Ingot — Hemostasis, LLC · U
- MEDLINE INDUSTRIES — MEDLINE INDUSTRIES, INC. · U
- Ostene — Apatech Ltd · U
- BoneSeal 3.5 gram Ingot — Hemostasis, LLC · U
- Ostene — Apatech Ltd · U
- Ostene — Apatech Ltd · U
- Abyrx Spatula — ABYRX, INC. · U
- AHBP 2.5 gram — ABYRX, INC. · U
Cleared under the same submission
K043260 also covers:
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
- Abyrx, Inc.
Sources (1)
- FDA UDI 27ebefbc-ad21-472d-aff5-ca45bd705af2 34 fields · synced May 29, 2026