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Midmark

FDA UDI

Class I (US FDA UDI)

by Midmark Corporation

Identity

Trade Name
Midmark FDA UDI
Generic Name
Operating/examination/treatment table headrest, reusable FDA UDI
Device Name
The Midmark 641 Flat Headrest, Deep Earth colored, is designed to help prevent pooling of liquids and allows for easier side-to-side movement of the patient's head. FDA UDI
Model / Reference
9A378001-854 FDA UDI
Description
The Midmark 641 Flat Headrest, Deep Earth colored, is designed to help prevent pooling of liquids and allows for easier side-to-side movement of the patient's head. FDA UDI

Identifiers

Catalog Number
9A378001-854 FDA UDI
Primary DI / UDI-DI
00841709113826 FDA UDI
FDA Product Code
GBB FDA UDI
GMDN Term
Operating/examination/treatment table headrest, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating/examination/treatment table headrest, reusable

Midmark by Midmark Corporation — 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
Midmark Corporation

Sources (1)

  • FDA UDI e9ce6f99-e3b3-40d8-b2ef-58f309ecb1fc 35 fields · synced Jun 8, 2026