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Elite

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name
ELITE FDA UDI
Generic Name
Operating/examination/treatment table headrest, reusable FDA UDI
Device Name
Medium ELITE Supine Headrest, medium is ideal for positioning and stabilizing the patient's head for all supine procedures with the added benefit of pressure management. FDA UDI
Model / Reference
BF467 FDA UDI
Description
Medium ELITE Supine Headrest, medium is ideal for positioning and stabilizing the patient's head for all supine procedures with the added benefit of pressure management. FDA UDI

Identifiers

Catalog Number
BF467 FDA UDI
Primary DI / UDI-DI
00724995219840 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Operating/examination/treatment table headrest, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating/examination/treatment table headrest, reusable

Elite by Steris 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
Steris Corporation

Sources (1)

  • FDA UDI 2ff59e0d-c7f8-47df-9b34-bdc91c26246e 36 fields · synced Jun 8, 2026