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BoneFoam

FDA UDI

Class I (US FDA UDI)

by Bone Foam, Inc.

Identity

Trade Name
BoneFoam FDA UDI
Generic Name
Leg/knee cushion FDA UDI
Device Name
Edema Reduction Leg Elevator Large - Box of 3 FDA UDI
Model / Reference
925.ERLE-L-BX3 FDA UDI
Description
Edema Reduction Leg Elevator Large - Box of 3 FDA UDI

Identifiers

Catalog Number
925.ERLE-L-BX3 FDA UDI
Primary DI / UDI-DI
00810075280678 FDA UDI
FDA Product Code
IQI FDA UDI
GMDN Term
Leg/knee cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 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

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

No

FDA UDI

Dimensions & Sizes

Size
Length — 37 Inch FDA UDI
Height — 11.5 Inch FDA UDI

Category: Leg/knee cushion

BoneFoam by Bone Foam, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Leg/knee cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bone Foam, Inc.

Sources (1)

  • FDA UDI e609549a-7e4d-4906-a13b-45d05ecea601 35 fields · synced May 31, 2026