Duns Number:005473608
Device Description: GC Reline ™ Extra Soft Intro Package 1 (48mL) cartridge of extra soft, 6 type 2L mixing ti GC Reline ™ Extra Soft Intro Package 1 (48mL) cartridge of extra soft, 6 type 2L mixing tips, 13mL bottle of Primer R, 1 silicone point, 9mL bottles of Reline Modifier Parts A 7 B, mixing pad, pellet sponges, spatula, scoop and brush
Catalog Number
000600
Brand Name
GC Reline ™
Version/Model Number
000600
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 13, 2017
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
-
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
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
144fe950-aa8c-41e6-9cfc-53dc64fd7e94
Public Version Date
August 09, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
D0470006002
Quantity per Package
5
Contains DI Package
D0470006001
Package Discontinue Date
November 13, 2017
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |