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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
Skin marking guide, reusable FDA UDI
Device Name
Pitanguy Flap Demarcator 10" (25cm), large FDA UDI
Model / Reference
405-602 FDA UDI
Description
Pitanguy Flap Demarcator 10" (25cm), large FDA UDI

Identifiers

Catalog Number
405-602 FDA UDI
Primary DI / UDI-DI
00840319710258 FDA UDI
FDA Product Code
GDJ FDA UDI
GMDN Term
Skin marking guide, 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Skin marking guide, reusable

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

Similar devices

Also classified as Skin marking guide, 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 6635c131-deb4-4bfa-871f-cb2f394046d5 35 fields · synced May 30, 2026