FRUIT HEALTH - 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, - Fruit of the Loom

Duns Number:110555005

Device Description: 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON- 100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK, NOT PROTECTED, SINGLE USE

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More Product Details

Catalog Number

-

Brand Name

FRUIT HEALTH

Version/Model Number

PI.408EGHT.O6J.L.0.0

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"

Yes

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 Details

Product Code

OEA

Product Code Name

Non-Surgical Isolation Gown

Device Record Status

Public Device Record Key

fd5274bd-37f8-4da5-8d10-4a6305a24b47

Public Version Date

March 21, 2022

Public Version Number

1

DI Record Publish Date

March 11, 2022

Additional Identifiers

Package DI Number

10194422075542

Quantity per Package

10

Contains DI Package

00194422075545

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

POLY BAG