Identity
- Trade Name
- OsteoPoint FDA UDI
- Generic Name
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
- Device Name
- HC Biologics OsteoPoint Bone & Tissue Trap FDA UDI
- Model / Reference
- HCT-BC-16 FDA UDI
- Description
- HC Biologics OsteoPoint Bone & Tissue Trap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647240382 FDA UDI
- FDA Product Code
- BYZ FDA UDI
- GMDN Term
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic surgery tissue debris collector, single-use
OsteoPoint by Morpheus AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgery tissue debris collector, single-use.
- Osseo II Bone Trap — XEMAX SURGICAL PRODUCTS, INC. · Class I
- DS Implants — Dentsply Implants Manufacturing GmbH · Class I
- Tobra Graft Compressor — TOBRA MEDICAL, INC. · Class II
- Fastgrafter — TREACE MEDICAL CONCEPTS, INC. · Class I
- Osteomedix, Inc. — OSTEOMEDIX, INC. · Class II
- Tobra Bone Basket — TOBRA MEDICAL, INC. · Class II
- spineX BONE DUST COLLECTOR — Oto-Med, Inc. · Class II
- PHANTOM BONE COLLECTOR, SINGLE-USE, STERILE — Morpheus AG · 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
- Morpheus AG
Sources (1)
- FDA UDI 3b80410f-5b7d-49f1-8d63-eeb3a08af66c 33 fields · synced May 30, 2026