Duns Number:109903521
Device Description: KIT INTERNATIONAL LENS 4K CCU NON WIFI
Catalog Number
72205264
Brand Name
LENS 4K
Version/Model Number
72205264
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
-
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
K191177
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
4ca56432-bbba-4919-bdef-bad1d0acb97e
Public Version Date
September 27, 2019
Public Version Number
1
DI Record Publish Date
September 19, 2019
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |