Catalog Number

SV*S25BL23B

Brand Name

SURSHIELD

Version/Model Number

SV*S25BL23B

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"

Yes

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

9c01644f-139c-41a6-b3ef-5a45008dd6bc

Public Version Date

August 22, 2019

Public Version Number

1

DI Record Publish Date

August 14, 2019

Package DI Number

56927675509388

Quantity per Package

10

Contains DI Package

36927675509384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton