Duns Number:689514395
Device Description: Accessories, Implant, Dental, Endosseous
Catalog Number
SOSRGSL
Brand Name
Simple Line II
Version/Model Number
SOSRGSL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
de4ae74b-150d-40c4-8aa4-c4675286188c
Public Version Date
May 25, 2020
Public Version Number
2
DI Record Publish Date
May 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 835 |
2 | A medical device with a moderate to high risk that requires special controls. | 1469 |