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Mayfield®

FDA UDI

Class I (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
MAYFIELD® FDA UDI
Generic Name
Operating/examination/treatment table headrest, reusable FDA UDI
Device Name
MAYFIELD® HORSESHOE HEADREST FDA UDI
Model / Reference
A1011 FDA UDI
Description
MAYFIELD® HORSESHOE HEADREST FDA UDI

Identifiers

Catalog Number
A1011 FDA UDI
Primary DI / UDI-DI
10381780267430 FDA UDI
FDA Product Code
HBM FDA UDI
GMDN Term
Operating/examination/treatment table headrest, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4440 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Operating/examination/treatment table headrest, reusable

Mayfield® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating/examination/treatment table headrest, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI ce9698f1-54c9-46ad-a19f-f730da2e25aa 36 fields · synced May 31, 2026