Catalog Number

SKAF-IM10

Brand Name

SKaffold

Version/Model Number

SKAF-IM10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Public Device Record Key

8217e3fb-8166-4b63-a7e4-9e52386988e0

Public Version Date

March 22, 2021

Public Version Number

6

DI Record Publish Date

October 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-