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Axial Handle, Trilobe Quick Connect, Ratcheting
EUDAMEDFDA UDIClass I (EU MDR)
Ref NoModel AR-8770RH
Identity
- Trade Name
- Bradshaw Medical, Inc. FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Axial Handle, Trilobe Quick Connect, Ratcheting EUDAMEDFDA UDI
- Model / Reference
- AR-8770RH EUDAMEDNo EUDAMEDRIV-18-15-01-A-B-C-ARTHREX FDA UDI
- Description
- Axial Handle, Trilobe Quick Connect, Ratcheting FDA UDI
Identifiers
- Catalog Number
- AR-8770RH FDA UDI
- Primary DI / UDI-DI
- 00810019932885 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081001993AR-8770RHSD EUDAMED
- Direct Marketing DI
- 00810019932885 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Axial Handle, Trilobe Quick Connect, Ratcheting by Bradshaw Medical Inc. — 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 | 0081001993AR-8770RHSD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bradshaw Medical Inc.
- EUDAMED SRN
- US-MF-000003392
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1c957250-5b82-45c5-9c47-f38facf7536f 61 fields · synced Jul 8, 2026
- FDA UDI 85a278d3-a136-4209-be76-8b1c0e62b6f3 34 fields · synced May 30, 2026