Duns Number:007198742
Device Description: Means of reconstruction of natural or surgically created defects of the mastoid lining the Means of reconstruction of natural or surgically created defects of the mastoid lining the canal wall or the attic of the tympanic cavity
Catalog Number
-
Brand Name
KARTUSH HA DISK 14MM HA
Version/Model Number
70921786
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K863237
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
257bcc54-dc67-4ad0-ad12-a1276912a7e3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |