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: Meyerding Hand-Held Retractor, 25mm x 60mm Dual Equal Blade Retraction, Each Blade has 8 Teeth at 60 Deg Angles, 7-7/8” Overall Length (20cm) with Ring Ratchet Handle, Surgical Grade Autoclavable Stainless Steel FDA UDI
Model / Reference: 15-VM5385 FDA UDI
Description: Meyerding Hand-Held Retractor, 25mm x 60mm Dual Equal Blade Retraction, Each Blade has 8 Teeth at 60 Deg Angles, 7-7/8” Overall Length (20cm) with Ring Ratchet Handle, Surgical Grade Autoclavable Stainless Steel FDA UDI

Identifiers

Catalog Number: 15-VM5385 FDA UDI
Primary DI / UDI-DI: 00198506083198 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

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable

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

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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 2e57ea19-407d-4bec-b776-68a05593e4af 35 fields · synced Jun 1, 2026