Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: Balfour Retractor with Spiked Retractor Pegs and X-Long 17” Frame for transplant surgical application w/dual rail x-long frame - 4.5cm x 48.5cm, dual sliding retainer bars w/fixed spiked retractor pegs- 2 each, stainless steel construction – hardened to specifications FDA UDI
Model / Reference: ST155617 FDA UDI
Description: Balfour Retractor with Spiked Retractor Pegs and X-Long 17” Frame for transplant surgical application w/dual rail x-long frame - 4.5cm x 48.5cm, dual sliding retainer bars w/fixed spiked retractor pegs- 2 each, stainless steel construction – hardened to specifications FDA UDI

Identifiers

Catalog Number: ST155617 FDA UDI
Primary DI / UDI-DI: 00842180192164 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

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

Similar devices

Also classified as Hand-held surgical retractor, reusable.

ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
Gimmi — Gimmi GmbH · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Sklar® — Sklar Corporation · Class I
BIOCOMPOSITE PLUS ANCHOR Ø3, 5 MM W/NEEDLE — BMT BAPS BİYO MALZEME SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class III
Spreizer / Spreader — REDA Instrumente GmbH · 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 055a2bda-6fc9-4891-8cc9-3a91f1e4547f 35 fields · synced Jun 8, 2026