Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Surgical retraction system, reusable FDA UDI
Device Name: ELMED RETRACT- ROBOT, SINGLE ARM TABLE MOUNT RETRACTOR WITH SWIVEL JOINT AND UNIVERSAL INSTRUMENT CLAMP, 20" VERICAL MOUNTING ROD, AUTOCLAVABLE MEDICAL GRADE STAINLESS STEEL. SPECIAL MADE INSTRUMENT CLAMP TO HOLD UP TO 30MM DIA. INSTRUMENT FDA UDI
Model / Reference: ST150880030 FDA UDI
Description: ELMED RETRACT- ROBOT, SINGLE ARM TABLE MOUNT RETRACTOR WITH SWIVEL JOINT AND UNIVERSAL INSTRUMENT CLAMP, 20" VERICAL MOUNTING ROD, AUTOCLAVABLE MEDICAL GRADE STAINLESS STEEL. SPECIAL MADE INSTRUMENT CLAMP TO HOLD UP TO 30MM DIA. INSTRUMENT FDA UDI

Identifiers

Catalog Number: ST150880030 FDA UDI
Primary DI / UDI-DI: 00842180191563 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Surgical retraction system, 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: Surgical retraction system, reusable

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

Similar devices

Also classified as Surgical retraction system, reusable.

45930R — Thompson Surgical Instruments, Inc. · Class IIa
Sigma — ALPHATEC SPINE, INC. · Class I
Omni-Tract® — Integra Lifesciences Corp. · Class I
Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
Thompson — Thompson Surgical Instruments · Class I
Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
Thompson — Thompson Surgical Instruments · Class I
Thompson — Thompson Surgical Instruments · 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

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Manufacturer

Manufacturer: Elmed Incorporated

Sources (1)

FDA UDI 91b1f9f4-e86a-4e8e-9422-9d4f23b3e827 35 fields · synced Jun 1, 2026