Catalog Number

SV-S25WL35C

Brand Name

SURFLO®

Version/Model Number

SV-S25WL35C

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

K133867,K133867,K133867

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

75d2865c-04dc-4a3e-936c-0a37f5cf717c

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

35413206246206

Quantity per Package

100

Contains DI Package

05413206246205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfbox