Elmed Incorporated

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED INCORPORATED FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: FIBEROPTIC RETRACTOR, 15CM X 30MM BLADE, RIGHT ANGLE TIP, SMOOTH, W/ SUCTION, GOLD PLATED HANDLE FDA UDI
Model / Reference: STT9932FSANGP FDA UDI
Description: FIBEROPTIC RETRACTOR, 15CM X 30MM BLADE, RIGHT ANGLE TIP, SMOOTH, W/ SUCTION, GOLD PLATED HANDLE FDA UDI

Identifiers

Catalog Number: STT9932FSANGP FDA UDI
Primary DI / UDI-DI: 00198506056611 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Hand-held surgical retractor, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable Fibreoptic retractor handle

A reliable and accurate source for surgical instruments, the ELMED INCORPORATED Hand-held Surgical Retractor is a versatile tool designed to facilitate precise retraction of tissues during open surgery. Requiring minimal training and expertise, this reusable device features a fibreoptic bundle for illumination and allows for controlled manipulation of the blade.

Similar devices

Also classified as Fibreoptic retractor handle.

Hayden Medical — Hayden Medical Inc · Class I
Hayden Medical — Hayden Medical Inc · Class I
Eikon — Stryker Corp. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
My Medical — MY MEDICAL STORE LLC · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Eikon — Stryker Corp. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Elmed Incorporated

Sources (1)

FDA UDI 69051218-6fe8-4c83-b793-9a934162b7d8 35 fields · synced Jul 6, 2026