Catalog Number

5952-463

Brand Name

BENCO DENTAL

Version/Model Number

FL 1530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K162362,K162362,K162362

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

9b98bc5a-42ed-4a06-b6f3-b25a252a8691

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Package DI Number

00850144008871

Quantity per Package

1

Contains DI Package

00850144008956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box