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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
Urethral sound, reusable FDA UDI
Device Name
McCrea Infant & Female Urethral Sound 7" (17.5cm), 12Fr. (4.0mm) FDA UDI
Model / Reference
285-202 FDA UDI
Description
McCrea Infant & Female Urethral Sound 7" (17.5cm), 12Fr. (4.0mm) FDA UDI

Identifiers

Catalog Number
285-202 FDA UDI
Primary DI / UDI-DI
00840319708118 FDA UDI
FDA Product Code
FBX FDA UDI
GMDN Term
Urethral sound, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5520 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: Urethral sound, reusable

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

Similar devices

Also classified as Urethral sound, reusable.

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 7e37db9e-e2fc-4a7c-9568-bac3a61be11e 35 fields · synced Jun 8, 2026