BENCO - Adult Molt Mouth Gag - BENCO DENTAL SUPPLY CO.

Duns Number:015108087

Device Description: Adult Molt Mouth Gag

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More Product Details

Catalog Number

-

Brand Name

BENCO

Version/Model Number

5095-587

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

-

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

0d6e2bf2-fb7b-4189-aae1-5190e3250be9

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BENCO 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 1364
2 A medical device with a moderate to high risk that requires special controls. 377
U Unclassified 15