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Reduction Instrument

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
REDUCTION INSTRUMENT FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, single-use FDA UDI
Device Name
CARROL GIRARD, SINGLE USE, 3.5 MM DIAMETER TIP FDA UDI
Model / Reference
38-708-00-07 FDA UDI
Description
CARROL GIRARD, SINGLE USE, 3.5 MM DIAMETER TIP FDA UDI

Identifiers

Primary DI / UDI-DI
00888118063243 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic bone-fragment manipulator, single-use 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

Yes

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

Category: Orthopaedic bone-fragment manipulator, single-use

Reduction Instrument by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone-fragment manipulator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
KLS-Martin L.P.

Sources (1)

  • FDA UDI 1c11c798-684d-4e3d-ba83-d96c39037f6b 35 fields · synced May 30, 2026