Catalog Number

ICP-3845

Brand Name

Protexer

Version/Model Number

ICP-3845

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

-

Product Code

FYE

Product Code Name

Dress, Surgical

Public Device Record Key

d2aab838-1eed-4786-8ffb-edddd0cc3910

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

February 03, 2022

Package DI Number

10813360021397

Quantity per Package

15

Contains DI Package

00813360021390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack