Catalog Number

900910

Brand Name

SaftiCuff DK

Version/Model Number

900910

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

FGD

Product Code Name

Catheter, Retention, Barium Enema With Bag

Public Device Record Key

662eddb2-38c3-48ba-a2b1-19d14e68c646

Public Version Date

June 30, 2020

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020904

Quantity per Package

75

Contains DI Package

10815112020900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box