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Mini Ratcheting Handle, AO Quick Connect
EUDAMEDFDA UDIClass I (EU MDR)
Ref NoModel AR-8700RH
Identity
- Trade Name
- Mini Ratcheting Handle, AO Quick Connect EUDAMEDBradshaw Medical, Inc. FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Mini Ratcheting Handle, AO Quick Connect EUDAMEDFDA UDI
- Model / Reference
- AR-8700RH EUDAMEDNo EUDAMEDRIV-16-18-02-C-A-CW-ARTHREX FDA UDI
- Description
- Mini Ratcheting Handle, AO Quick Connect FDA UDI
Identifiers
- Catalog Number
- AR-8700RH FDA UDI
- Primary DI / UDI-DI
- 00810019932878 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081001993AR-8700RHQU EUDAMED
- Direct Marketing DI
- 00810019932878 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
Mini Ratcheting Handle, AO Quick Connect 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-8700RHQU | 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 8f3f87ca-84d9-4143-adae-011d114bda84 61 fields · synced Jul 11, 2026
- FDA UDI f000cb2f-11cb-43e8-8453-9023057f5d96 35 fields · synced May 30, 2026