Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name: ELMED FDA UDI
Generic Name: Rectal speculum FDA UDI
Device Name: Fiberoptic Sawyer Rectal Retractor, Large, 38mm x 89mm FDA UDI
Model / Reference: ST305503F FDA UDI
Description: Fiberoptic Sawyer Rectal Retractor, Large, 38mm x 89mm FDA UDI

Identifiers

Catalog Number: ST305503F FDA UDI
Primary DI / UDI-DI: 00198506001390 FDA UDI
FDA Product Code: FFQ FDA UDI
GMDN Term: Rectal speculum FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 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: Rectal speculum

Elmed 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 59ed0eac-e7aa-4022-a61c-fcff092c4d7e 35 fields · synced May 30, 2026