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LexTOME

FDA UDI

Class I (US FDA UDI)

by Medmetalex Co., Ltd.

Identity

Trade Name
LexTOME FDA UDI
Generic Name
Ligament reconstruction instrument set, reusable FDA UDI
Device Name
ACETABULAR REAMER CONTAINER FDA UDI
Model / Reference
MUA00048 FDA UDI
Description
ACETABULAR REAMER CONTAINER FDA UDI

Identifiers

Catalog Number
MUA00048 FDA UDI
Primary DI / UDI-DI
04589761815802 FDA UDI
FDA Product Code
PXV FDA UDI
GMDN Term
Ligament reconstruction instrument set, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

No

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: Ligament reconstruction instrument set, reusable

LexTOME by Medmetalex Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ligament reconstruction instrument set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medmetalex Co., Ltd.

Sources (1)

  • FDA UDI bb035089-fa1b-4a69-95d6-9457605a5cf3 34 fields · synced Jun 1, 2026