Precaution Gown - Generic Polyester Precaution Gown, Bound Neck - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: Generic Polyester Precaution Gown, Bound Neck With Adjustable Snap Closure, Long Sleeves W Generic Polyester Precaution Gown, Bound Neck With Adjustable Snap Closure, Long Sleeves With White Poly Cuffs, Size XL

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More Product Details

Catalog Number

66124385

Brand Name

Precaution Gown

Version/Model Number

66124385

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)

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

bd8121f6-75ea-41f0-919e-86d2a9fe44d5

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANDARD TEXTILE CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 9