Duns Number:626406016
Device Description: Resin Optimized Temporary Cement
Catalog Number
158910
Brand Name
CLING2™ 10ml Dual Syringe Kit
Version/Model Number
158910
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EID
Product Code Name
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
Public Device Record Key
fb9f87a2-ab69-472e-a41f-e02b68aa040e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
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 | 1461 |
2 | A medical device with a moderate to high risk that requires special controls. | 234 |
U | Unclassified | 6 |