OEM - WHITE STRETCH VINYL EXAM PF - SMALL 1/10/100 - CLEAN SAFETY INC.

Duns Number:079147322

Device Description: WHITE STRETCH VINYL EXAM PF - SMALL 1/10/100

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More Product Details

Catalog Number

-

Brand Name

OEM

Version/Model Number

GSF3001

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Device Record Status

Public Device Record Key

34dcce2e-f0c5-412d-901e-94dc1523fe4c

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Additional Identifiers

Package DI Number

00851685006319

Quantity per Package

10

Contains DI Package

10851685006316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CLEAN SAFETY INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 89