Catalog Number

-

Brand Name

Caroli

Version/Model Number

extra

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

9e5b6e9e-7716-4731-bce7-04974146e6b4

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Package DI Number

04000576083397

Quantity per Package

12

Contains DI Package

04009408027011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-