Full Coverage Isolation Gown #RR-300FC - Isolation Gown, SMS, AAMI Level 3, Full Coverage, - ICP MEDICAL, LLC

Duns Number:078780963

Device Description: Isolation Gown, SMS, AAMI Level 3, Full Coverage, Over the Head, Thumbloop with Elastic Wr Isolation Gown, SMS, AAMI Level 3, Full Coverage, Over the Head, Thumbloop with Elastic Wrist, Universal

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More Product Details

Catalog Number

RR300FC

Brand Name

Full Coverage Isolation Gown #RR-300FC

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Device Record Status

Public Device Record Key

796d0eed-c96f-48d6-999e-e8216e8fc6e8

Public Version Date

October 27, 2022

Public Version Number

5

DI Record Publish Date

January 04, 2017

Additional Identifiers

Package DI Number

20813360023046

Quantity per Package

10

Contains DI Package

10813360023049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ICP MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1