Identity
- Trade Name
- WRENCH, 5mm HEX FDA UDI
- Generic Name
- Spine board FDA UDI
- Device Name
- A wrench, 5mm hex is a non-powered, hand-held surgical instrument used to assemble, adjust, and secure the various components of a modular retractor system FDA UDI
- Model / Reference
- MRS-114 FDA UDI
- Description
- A wrench, 5mm hex is a non-powered, hand-held surgical instrument used to assemble, adjust, and secure the various components of a modular retractor system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019931871 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spine board FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spine board
WRENCH, 5mm HEX by Bradshaw Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spine board.
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- EM — Allied Medical LLC · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- Spencer — SPENCER ITALIA SRL · Class I
- MORRISON MEDICAL — MORRISON MEDICAL, LTD · Class I
- EMSRUN — Wuxi Emsrun Technology Co., Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bradshaw Medical Inc.
Sources (1)
- FDA UDI 1da22f4e-eb9a-4f89-8b3f-df13c2dcde98 33 fields · synced May 31, 2026