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Level One Thoracic, Sterile

FDA UDI

Class II (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
LEVEL ONE THORACIC, STERILE FDA UDI
Generic Name
Orthopaedic bone-fragment manipulator, single-use FDA UDI
Device Name
TEMPORARY FIXATION SCREW INSTRUMENT, RIB, MAXDRIVE, TI-6AL-4V FDA UDI
Model / Reference
24-015-64-71 FDA UDI
Description
TEMPORARY FIXATION SCREW INSTRUMENT, RIB, MAXDRIVE, TI-6AL-4V FDA UDI

Identifiers

Primary DI / UDI-DI
00888118131287 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Orthopaedic bone-fragment manipulator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone-fragment manipulator, single-use

Level One Thoracic, Sterile by KLS-Martin L.P. — Class II — 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 23c6861b-8e0a-4781-8b07-444faf069303 35 fields · synced May 30, 2026