Medi-First Plus Sani Safe Glove Dispenser - Polymer patient exam gloves in a dispenser. - Medique Products

Duns Number:086911794

Device Description: Polymer patient exam gloves in a dispenser.

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More Product Details

Catalog Number

7915MFP

Brand Name

Medi-First Plus Sani Safe Glove Dispenser

Version/Model Number

7915MFP

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

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

567d49ec-8bb5-4c9f-b5c5-19de06873864

Public Version Date

July 22, 2019

Public Version Number

1

DI Record Publish Date

July 12, 2019

Additional Identifiers

Package DI Number

50347682791570

Quantity per Package

24

Contains DI Package

00347682791513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master case

"MEDIQUE PRODUCTS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 110
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1