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Bio-Flek

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Bio-Flek FDA UDI
Generic Name
Operating/examination/treatment table headrest, reusable FDA UDI
Device Name
HEAD SUPPORT 1358227 BIOFLEK RISER FDA UDI
Model / Reference
1358227 FDA UDI
Description
HEAD SUPPORT 1358227 BIOFLEK RISER FDA UDI

Identifiers

Primary DI / UDI-DI
00763000299118 FDA UDI
FDA Product Code
EPW 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

Yes

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

Category: Operating/examination/treatment table headrest, reusable

Bio-Flek by Medtronic Xomed, Inc. — 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
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 6967c348-007b-4af2-99b6-0f23ea4a1af7 34 fields · synced May 31, 2026