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Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name
Hayden Medical FDA UDI
Generic Name
Rectal speculum FDA UDI
Device Name
Brinkerhoff Rectal Speculum, large size, 4-3/4" (11.9cm) long, 1-1/4" (3.1cm) to 3/4" (1.9cm) taper FDA UDI
Model / Reference
280-034 FDA UDI
Description
Brinkerhoff Rectal Speculum, large size, 4-3/4" (11.9cm) long, 1-1/4" (3.1cm) to 3/4" (1.9cm) taper FDA UDI

Identifiers

Catalog Number
280-034 FDA UDI
Primary DI / UDI-DI
00840319722763 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rectal speculum

Hayden Medical by Hayden Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal speculum.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hayden Medical Inc

Sources (1)

  • FDA UDI 2fdd7289-22e9-447c-827d-7a7dae8be174 35 fields · synced May 31, 2026