Catalog Number

-

Brand Name

Caroli

Version/Model Number

mini plus

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

153fe8f5-60d9-453e-9341-a0fd5b1cabeb

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Package DI Number

04000576019891

Quantity per Package

16

Contains DI Package

04009408027042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-