AD Surgical - ChloroSense Polychloroprene Surgical Gloves, - APPLIED DENTAL, INC.

Duns Number:017524666

Device Description: ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile. Size 8. ChloroSense Polychloroprene Surgical Gloves, Non-Latex and Powder Free. Sterile. Size 8.0 (pair).

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More Product Details

Catalog Number

-

Brand Name

AD Surgical

Version/Model Number

A501-C80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

KGO

Product Code Name

Surgeon'S Gloves

Device Record Status

Public Device Record Key

290094a3-0ddd-4ac7-9a28-aca9756c1db8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10814639023128

Quantity per Package

50

Contains DI Package

00814639023121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"APPLIED DENTAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 121