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Oakworks, Inc.

FDA UDI

Class II (US FDA UDI)

by Oakworks, Inc.

Identity

Trade Name
Oakworks, Inc. FDA UDI
Generic Name
Freestanding headrest, reusable FDA UDI
Device Name
Interventional Supine Pillow System FDA UDI
Model / Reference
Interventional Supine Pillow System FDA UDI
Description
Interventional Supine Pillow System FDA UDI

Identifiers

Primary DI / UDI-DI
00817463022445 FDA UDI
FDA Product Code
IZZ FDA UDI
MMZ FDA UDI
IXR FDA UDI
GMDN Term
Freestanding headrest, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
876.4890 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

Yes

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: Freestanding headrest, reusable

Oakworks, Inc. by Oakworks, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Freestanding headrest, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oakworks, Inc.

Sources (1)

  • FDA UDI 7557139e-500c-420c-9b38-e0d700695d5e 33 fields · synced Jun 8, 2026