VR - Sleeve Gloves 15 Mil Medium Green Unlined - POLYCONVERSIONS, INC.

Duns Number:825056401

Device Description: Sleeve Gloves 15 Mil Medium Green Unlined

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More Product Details

Catalog Number

-

Brand Name

VR

Version/Model Number

41460

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

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

LZB

Product Code Name

Finger Cot

Device Record Status

Public Device Record Key

85800d85-f3b3-430f-9119-cb79d10714f1

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POLYCONVERSIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 133