Catalog Number

-

Brand Name

BoneCam

Version/Model Number

08-12106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

K152255,K152255

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

8074a779-9544-4f48-98d4-aaa3105c5fea

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

August 17, 2017

Package DI Number

10818614021055

Quantity per Package

5

Contains DI Package

00818614021058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box