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K2M General Instruments

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
K2M General Instruments FDA UDI
Generic Name
Torque manipulation device FDA UDI
Device Name
Anti Torque Alignment Tube Size 75° FDA UDI
Model / Reference
PRO-1205-02 FDA UDI
Description
Anti Torque Alignment Tube Size 75° FDA UDI

Identifiers

Catalog Number
PRO-1205-02 FDA UDI
Primary DI / UDI-DI
10888857554375 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Torque manipulation device 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 75 degree FDA UDI

Category: Torque manipulation device

K2M General Instruments by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Torque manipulation device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 525b254f-bc45-4f0a-9884-2ea548e19023 36 fields · synced May 30, 2026