Duns Number:005473608
Device Description: Initial LiSi Block 14 Unvsl B1 LT 5p
Catalog Number
013009
Brand Name
GC Initial™
Version/Model Number
013009
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
Yes
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
K153130,K153130
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
ab559ae0-35f6-49a5-8393-4ac24be77caf
Public Version Date
October 13, 2021
Public Version Number
1
DI Record Publish Date
October 05, 2021
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 | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 4772 |