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Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED INCORPORATED FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
LASER BLACK IRIS HOOKS, QUICK RELEASE, 1MM TIP SIZE, 9” OVERALL LENGTH, STYLE #1 FDA UDI
Model / Reference
ST3250901E FDA UDI
Description
LASER BLACK IRIS HOOKS, QUICK RELEASE, 1MM TIP SIZE, 9” OVERALL LENGTH, STYLE #1 FDA UDI

Identifiers

Catalog Number
ST3250901E FDA UDI
Primary DI / UDI-DI
00198506069468 FDA UDI
FDA Product Code
GDG FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, non-medicated, 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

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: Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as Obstetrical/gynaecological 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 dc454c03-6b17-48ef-a5d0-70401ae9de95 35 fields · synced Jun 8, 2026