Catalog Number

-

Brand Name

Assistant with StableSoft™ 3L Flex

Version/Model Number

T401213S

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)

Yes

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

b3b9304d-9e7d-4609-a65b-fc16ccb92ba2

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

50699753450924

Quantity per Package

5

Contains DI Package

00699753450929

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case