Identity
- Trade Name
- Combined Adapter FDA UDI
- Generic Name
- Collection syringe adaptor, reusable FDA UDI
- Device Name
- Combined Adapter EUDAMEDThe Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures. FDA UDI
- Model / Reference
- ADAPT/PURE EUDAMEDFDA UDI
- Description
- The Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034511016 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850034511ADAPTKN EUDAMED
- Direct Marketing DI
- 00850034511016 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Collection syringe adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Combined Adapter by Bimini Health Tech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850034511ADAPTKN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bimini Health Tech
- EUDAMED SRN
- US-MF-000008649
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9db05251-a540-4cd7-b438-ebd2dfa3fcaf 61 fields · synced Jul 10, 2026
- FDA UDI cbca0b1e-3ea7-44ca-9e38-cd9ac7baafac 33 fields · synced May 22, 2026