Duns Number:005473608
Device Description: GC Initial™ LiSi Press Ingot MO-1 (3g x 5)
Catalog Number
010341
Brand Name
GC Initial™
Version/Model Number
010341
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K153136,K153136
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
5cf5674c-47ac-441d-82ba-411723a3488d
Public Version Date
July 24, 2018
Public Version Number
4
DI Record Publish Date
November 14, 2016
Package DI Number
D0470103414
Quantity per Package
15
Contains DI Package
D0470103411
Package Discontinue Date
-
Package Status
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 |