Catalog Number

5104-G30

Brand Name

Safesider HF

Version/Model Number

5104-G30

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EKM

Product Code Name

GUTTA-PERCHA

Public Device Record Key

9b07b0d0-9ce7-4c96-bd79-4f69a38a3b2b

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-