Duns Number:532176000
Device Description: Box of 6 Medium cartridges 25mm Diameter and 73mm long,18gr. net of Thermoplastic T-CRYSTA Box of 6 Medium cartridges 25mm Diameter and 73mm long,18gr. net of Thermoplastic T-CRYSTAL Standard Pink filled inside of each cartridge sealed in aluminum bag,the cartridges are suitable for 25mm thermoplastic injector machines
Catalog Number
112506
Brand Name
Perflex T-CRYSTAL
Version/Model Number
Cartridge STD Pink Medium Diameter 25mm
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150454
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
ec980891-bf74-4391-9777-ea2be8a237bb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 14, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |