Catalog Number

-

Brand Name

3D Dental- Bioviva

Version/Model Number

SCG1638

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

2a1fe5db-f6f3-417b-9a03-7720d1edc5c5

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

December 04, 2017

Package DI Number

10817169021510

Quantity per Package

12

Contains DI Package

00817169021513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-