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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
SKIN HOOK; FIXATION, 2 PRONG, 2MM, 12.5CM FDA UDI
Model / Reference
19212-02 FDA UDI
Description
SKIN HOOK; FIXATION, 2 PRONG, 2MM, 12.5CM FDA UDI

Identifiers

Catalog Number
19212-02 FDA UDI
Primary DI / UDI-DI
00842180173828 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT surgical procedure kit, non-medicated, reusable

A comprehensive medical device directory featuring the ELMED skin hook fixator, designed for ENT surgical procedures. This kit is suitable for use in various ENT surgical procedures and does not contain pharmaceuticals or MRI safety information.

Similar devices

Also classified as ENT surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 0d0700b2-05ea-4caa-8f64-79e9d464b976 35 fields · synced Jul 21, 2026