Duns Number:751548632
Device Description: Replacement crown and repair for ABC+E prosthesis
Catalog Number
SGI104
Brand Name
Stoneglass Industries
Version/Model Number
SGI104
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
af7a2d22-7a94-45f2-91ee-90233e9dd8c8
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-