Catalog Number

SC40001901S

Brand Name

SyntheCel

Version/Model Number

SC.400.019.01S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K113071,K131792,K212943

Product Code

GXQ

Product Code Name

DURA SUBSTITUTE

Public Device Record Key

4302dcfb-e29b-43c9-9c13-5f57e4da6054

Public Version Date

April 25, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-