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Individual Head Support

FDA UDI

Class II (US FDA UDI)

by Medtec LLC

Identity

Trade Name
Individual Head Support FDA UDI
Generic Name
Radiological headrest FDA UDI
Device Name
Non-sterile normal profile individual head support with pin base FDA UDI
Model / Reference
MTIHS03 FDA UDI
Description
Non-sterile normal profile individual head support with pin base FDA UDI

Identifiers

Catalog Number
MTIHS03 FDA UDI
Primary DI / UDI-DI
00841439104408 FDA UDI
510(k) Number
K982624 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Radiological headrest FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 12.2 Inch FDA UDI
Width — 8.6 Inch FDA UDI

Individual Head Support by Medtec LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K982624 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtec LLC

Sources (1)

  • FDA UDI 1c8bd509-120a-4412-b75f-5cf26390c7bc 39 fields · synced Jun 1, 2026