Dealmed - Glove Exam Nitrile N/S PF Small Blue, 200/Bx - DEALMED MEDICAL SUPPLIES LLC

Duns Number:068586441

Device Description: Glove Exam Nitrile N/S PF Small Blue, 200/Bx

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More Product Details

Catalog Number

787360

Brand Name

Dealmed

Version/Model Number

787360

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071740,K071740,K071740

Product Code Details

Product Code

LZA

Product Code Name

Polymer patient examination glove

Device Record Status

Public Device Record Key

04e9d76e-caf8-41c5-94ff-61e5591f4a9d

Public Version Date

October 02, 2020

Public Version Number

2

DI Record Publish Date

September 11, 2020

Additional Identifiers

Package DI Number

10859140003399

Quantity per Package

10

Contains DI Package

00859140003392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"DEALMED MEDICAL SUPPLIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 6