Torque Limiter Ball Handle

FDA UDI

Class II (US FDA UDI)

by Miami Device Solutions

Identity

Trade Name: Torque Limiter Ball Handle FDA UDI
Generic Name: Surgical instrument torque limiter FDA UDI
Device Name: Torque Limiter Ball Handle, AO, 1.5Nm, Green FDA UDI
Model / Reference: MDS000604AOT FDA UDI
Description: Torque Limiter Ball Handle, AO, 1.5Nm, Green FDA UDI

Identifiers

Catalog Number: MDS000604AOT FDA UDI
Primary DI / UDI-DI: 10812269022047 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Surgical instrument torque limiter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Surgical instrument torque limiter

Torque Limiter Ball Handle by Miami Device Solutions — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Miami Device Solutions

Sources (1)

FDA UDI 8a595a95-f025-491c-a9fb-d999e205b16c 35 fields · synced May 30, 2026