Bone Foam - Knee Buddy Extender - Box of 4 - BONE FOAM, INC.

Duns Number:079636174

Device Description: Knee Buddy Extender - Box of 4

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More Product Details

Catalog Number

925.KBEX-BX4

Brand Name

Bone Foam

Version/Model Number

925.KBEX-BX4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IQI

Product Code Name

ORTHOSIS, LIMB BRACE

Device Record Status

Public Device Record Key

02065a75-ba54-4eba-95f0-389705f4be8d

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BONE FOAM, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 97
2 A medical device with a moderate to high risk that requires special controls. 11