CONDOR - Gloves,Blue,L,Exam,PR,PK100 - GRAINGER INTERNATIONAL, INC.

Duns Number:053618240

Device Description: Gloves,Blue,L,Exam,PR,PK100

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More Product Details

Catalog Number

-

Brand Name

CONDOR

Version/Model Number

48UM36

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

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

dd19a364-ec43-407b-bf46-3c0ffb8d8dc2

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Additional Identifiers

Package DI Number

20194484319773

Quantity per Package

10

Contains DI Package

10194484319776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"GRAINGER INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1