Catalog Number

S8081

Brand Name

Soft-Release-Micro

Version/Model Number

S8081

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

c042cd5d-a493-4bbb-adfa-93e79a48ba48

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Package DI Number

07613117017651

Quantity per Package

10

Contains DI Package

07613117017521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHIPPER BOX