Pro-V C&B A1 50ml Syr. - BISCO INC.

Duns Number:053529939

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More Product Details

Catalog Number

H-403A1

Brand Name

Pro-V C&B A1 50ml Syr.

Version/Model Number

H-403A1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In HIBCC

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)

Yes

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

e723218d-2c82-47b4-8862-21dbd1e8d845

Public Version Date

March 15, 2021

Public Version Number

3

DI Record Publish Date

November 21, 2018

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