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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
Hand-held surgical retractor, reusable FDA UDI
Device Name
LASER BLACK RICHARDSON EASTMAN, RETRACTOR, LARGE, 1 3/4” X 1 1/2”/2 1/2” X 1 5/8” FDA UDI
Model / Reference
ST322502E FDA UDI
Description
LASER BLACK RICHARDSON EASTMAN, RETRACTOR, LARGE, 1 3/4” X 1 1/2”/2 1/2” X 1 5/8” FDA UDI

Identifiers

Catalog Number
ST322502E FDA UDI
Primary DI / UDI-DI
00198506070044 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

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: Hand-held surgical retractor, reusable

Elmed Incorporated 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 027885db-7631-4687-ba51-539210cf0c9f 35 fields · synced May 31, 2026