BENCO - Spatula Cement #22 (322) - BENCO DENTAL SUPPLY CO.

Duns Number:015108087

Device Description: Spatula Cement #22 (322)

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More Product Details

Catalog Number

-

Brand Name

BENCO

Version/Model Number

5094-471

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

GDZ

Product Code Name

Handle, Scalpel

Device Record Status

Public Device Record Key

73c8fd16-a3cd-41bc-b22b-1b6c7415c8a4

Public Version Date

December 21, 2018

Public Version Number

2

DI Record Publish Date

October 31, 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