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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Patient monitoring system module, interfacing FDA UDI
Device Name
LEKSELL BONE RONGEUR; 9", SLIGHT CURVE, 5MM BITE FDA UDI
Model / Reference
23-230267 FDA UDI
Description
LEKSELL BONE RONGEUR; 9", SLIGHT CURVE, 5MM BITE FDA UDI

Identifiers

Catalog Number
23-230267 FDA UDI
Primary DI / UDI-DI
00842180188198 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Patient monitoring system module, interfacing 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Patient monitoring system module, interfacing

Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, interfacing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 0fad864c-23e9-4639-af8f-15024f7e2691 35 fields · synced Jun 1, 2026