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DRIVER, 3.5mm HEX

FDA UDI

Class I (US FDA UDI)

by Bradshaw Medical Inc.

Identity

Trade Name
DRIVER, 3.5mm HEX FDA UDI
Generic Name
Protective barrier strike-through detector FDA UDI
Device Name
A driver, 3.5mm hex is a specialized, hand-held surgical instrument used in orthopedic and spinal procedures. Its specific function is to apply torque to a screw, which in this case is used to fix a threaded shim into a vertebra. FDA UDI
Model / Reference
MRS-118 FDA UDI
Description
A driver, 3.5mm hex is a specialized, hand-held surgical instrument used in orthopedic and spinal procedures. Its specific function is to apply torque to a screw, which in this case is used to fix a threaded shim into a vertebra. FDA UDI

Identifiers

Primary DI / UDI-DI
00810019931987 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Protective barrier strike-through detector 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Protective barrier strike-through detector

DRIVER, 3.5mm HEX by Bradshaw Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bradshaw Medical Inc.

Sources (1)

  • FDA UDI 52b331ec-fe0c-4b8d-bd78-5f63ea7c55ed 33 fields · synced Jun 8, 2026