Pure Grip - Pure Grip Medium - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Pure Grip Medium

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More Product Details

Catalog Number

1032504

Brand Name

Pure Grip

Version/Model Number

1032504

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)

Yes

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

LYY

Product Code Name

Latex patient examination glove

Device Record Status

Public Device Record Key

271731f1-5041-4d9f-9cb9-0f44a3dc006d

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 08, 2019

Additional Identifiers

Package DI Number

10304040005054

Quantity per Package

20

Contains DI Package

00304040005057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34