Catalog Number

-

Brand Name

Carerite®

Version/Model Number

1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K870147,K870147

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

1a625030-1155-49f9-8973-9a38ed317b6a

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 18, 2017

Package DI Number

17290016678038

Quantity per Package

12

Contains DI Package

07290016678031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case