MAMMOGRAPHY GOWN - Mammography Gown, Front Lapover, inside & outside - STANDARD TEXTILE CO., INC.

Duns Number:006999858

Device Description: Mammography Gown, Front Lapover, inside & outside ties at front waist, 3/4 length sleeves,

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More Product Details

Catalog Number

74347089

Brand Name

MAMMOGRAPHY GOWN

Version/Model Number

74347089

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

FME

Product Code Name

Gown, Examination

Device Record Status

Public Device Record Key

bc96adec-0087-4544-84be-bc940e52d039

Public Version Date

June 04, 2018

Public Version Number

1

DI Record Publish Date

May 03, 2018

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