FluoroCal - FluoroCal 50ct Unit Dose PkgSpearmint - BISCO INC.

Duns Number:053529939

Device Description: FluoroCal 50ct Unit Dose PkgSpearmint

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More Product Details

Catalog Number

B-30501K

Brand Name

FluoroCal

Version/Model Number

B-30501K

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182917,K182917

Product Code Details

Product Code

LBH

Product Code Name

Varnish, Cavity

Device Record Status

Public Device Record Key

395f3600-db90-4349-aa3c-cc1baa683457

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BISCO INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 335
2 A medical device with a moderate to high risk that requires special controls. 675