Catalog Number

900911

Brand Name

Safti Cuff

Version/Model Number

900911

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

FGD

Product Code Name

Catheter, Retention, Barium Enema With Bag

Public Device Record Key

fc42ebab-ef24-45aa-9de8-f8c59402842a

Public Version Date

June 30, 2020

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020911

Quantity per Package

75

Contains DI Package

10815112020917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box