Catalog Number

ICP-8300

Brand Name

Protexer

Version/Model Number

ICP-8300

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

2c4d2279-2b55-408d-ac62-7e646b858a93

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

January 17, 2022

Package DI Number

10813360021588

Quantity per Package

10

Contains DI Package

00813360021581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack