Safco EZ Green Chloroprene - Safco EZ Green Chloroprene gloves X-small 200/box - SAFCO DENTAL SUPPLY CO.

Duns Number:020417380

Device Description: Safco EZ Green Chloroprene gloves X-small 200/box

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More Product Details

Catalog Number

1028046

Brand Name

Safco EZ Green Chloroprene

Version/Model Number

1028046

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

bb057c05-dd40-4bb5-9d61-16d981a12bc4

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFCO DENTAL SUPPLY CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 600
2 A medical device with a moderate to high risk that requires special controls. 23