Catalog Number

77075

Brand Name

Covidien

Version/Model Number

77075

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EYQ

Product Code Name

GARMENT, PROTECTIVE, FOR INCONTINENCE

Public Device Record Key

0457005b-8662-4d2e-9dbe-c53f553ad7a7

Public Version Date

June 19, 2020

Public Version Number

1

DI Record Publish Date

June 11, 2020

Package DI Number

50192253022856

Quantity per Package

4

Contains DI Package

00192253022851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE