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Oakworks Medical

FDA UDI

Class II (US FDA UDI)

by Oakworks, Inc.

Identity

Trade Name
Oakworks Medical FDA UDI
Generic Name
Radiological general body-part positioner FDA UDI
Device Name
CFPMFXH with Integrated Top + 2" Table Top Pad + 5" Casters FDA UDI
Model / Reference
CFPMFXH FDA UDI
Description
CFPMFXH with Integrated Top + 2" Table Top Pad + 5" Casters FDA UDI

Identifiers

Primary DI / UDI-DI
00817463020908 FDA UDI
FDA Product Code
IXR FDA UDI
GMDN Term
Radiological general body-part positioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 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

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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oakworks, Inc.

Sources (1)

  • FDA UDI c248804b-98d7-4653-8678-bc3c08fc83a8 34 fields · synced May 31, 2026