ValuLine - POUCH VALULINE 5.25X10 BX200 - BENCO DENTAL SUPPLY CO.

Duns Number:015108087

Device Description: POUCH VALULINE 5.25X10 BX200

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More Product Details

Catalog Number

-

Brand Name

ValuLine

Version/Model Number

4756-427

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

ca0fcd24-ab5a-4f56-8fc8-86e70c7a5134

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10366975003017

Quantity per Package

10

Contains DI Package

00366975003010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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