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Knochen- und Gewebefalle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BC-16
by Morpheus AG
Identity
- Trade Name
- Knochen- und Gewebefalle EUDAMEDRebellion Tissue Trap FDA UDI
- Generic Name
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
- Device Name
- Knochen- und Gewebefalle EUDAMEDBone and Tissue Trap FDA UDI
- Model / Reference
- BC-16 EUDAMEDFDA UDI
- Description
- Bone and Tissue Trap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647240122 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260647240122 EUDAMED
- FDA Product Code
- BYZ FDA UDI
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgery tissue debris collector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Knochen- und Gewebefalle by Morpheus AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260647240122 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Morpheus AG
- EUDAMED SRN
- DE-MF-000012037
Sources (2)
- EUDAMED 7c419522-116f-4cba-8407-0821c5f7e516 61 fields · synced Jun 19, 2026
- FDA UDI bc69acfb-b90f-4d62-ac6f-00c5b6ea60ec 33 fields · synced May 25, 2026