Medline - GOWN, ORBIS, XLONG/XLARGE, STERILE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: GOWN, ORBIS, XLONG/XLARGE, STERILE

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More Product Details

Catalog Number

DYNJP2372P

Brand Name

Medline

Version/Model Number

DYNJP2372P

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

FYA

Product Code Name

GOWN, SURGICAL

Device Record Status

Public Device Record Key

632abfeb-2d34-4916-8a16-e4b1f4c27d78

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 10, 2020

Additional Identifiers

Package DI Number

20888277725611

Quantity per Package

24

Contains DI Package

10888277725614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7