Duns Number:116708692
Device Description: Disposable accessory kit to be used with IntraVu Scope 120.Kit contains 120mm cannula, 120 Disposable accessory kit to be used with IntraVu Scope 120.Kit contains 120mm cannula, 120mm trocar, cannula cap and stopcock.
Catalog Number
IV-ASY-1612
Brand Name
AccessVu 120
Version/Model Number
IV-ASY-1612
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
K181982
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
a818ad41-4c50-43ca-9414-c954530d1b2d
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |