Duns Number:065016344
Device Description: ZEOS HD CAMERA CONTROL UNIT, JPN
Catalog Number
84-10-2410
Brand Name
ZEOS
Version/Model Number
84-10-2410
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
c3476e8f-2e1a-4dcd-b9fa-44ce31cace0f
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
October 25, 2019
Package DI Number
00812231031995
Quantity per Package
1
Contains DI Package
00812231031896
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Loaner
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |