Catalog Number

SGI65

Brand Name

Stoneglass Industries

Version/Model Number

SGI65

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2999

Issuing Agency

In HIBCC

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

NSN

Product Code Name

Restoration, Resin, Crown And Bridge

Public Device Record Key

69a6a388-e2e6-49bd-8749-7a2761e34661

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-