Arm (Articulated Arm for Radial Clamp)

FDA UDI

Class I (US FDA UDI)

by Bradshaw Medical Inc.

Identity

Trade Name: Arm (Articulated Arm for Radial Clamp) FDA UDI
Generic Name: Breathing circuit tube holder FDA UDI
Device Name: The Arm (Articulated Arm for Radial Clamp) is a non-powered, reusable, hand-held surgical instrument designed for use in orthopedic surgery. Its primary function is to provide stable, adjustable support for other manual surgical instruments and devices used to manipulate tissue during orthopedic procedures. The device is an "assist arm" that effectively serves as an extension of the surgical team, holding orthopedic instruments like retractors, awls, or probes in a fixed position, thereby enhancing surgical efficiency and precision in orthopedic applications. FDA UDI
Model / Reference: MRS-115 FDA UDI
Description: The Arm (Articulated Arm for Radial Clamp) is a non-powered, reusable, hand-held surgical instrument designed for use in orthopedic surgery. Its primary function is to provide stable, adjustable support for other manual surgical instruments and devices used to manipulate tissue during orthopedic procedures. The device is an "assist arm" that effectively serves as an extension of the surgical team, holding orthopedic instruments like retractors, awls, or probes in a fixed position, thereby enhancing surgical efficiency and precision in orthopedic applications. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810019931888 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Breathing circuit tube holder 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Breathing circuit tube holder

Arm (Articulated Arm for Radial Clamp) by Bradshaw Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 69fca43e-2e7e-4646-a44a-b286b5e41096 33 fields · synced Jun 1, 2026