Catalog Number

-

Brand Name

Bioviva by 3D Dental

Version/Model Number

SCG1637

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAL

Product Code Name

Suture, Absorbable, Natural

Public Device Record Key

d16b0a81-4c93-4cb0-9d0f-0f896fa2f834

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Package DI Number

10817169023040

Quantity per Package

12

Contains DI Package

00817169023043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-