Duns Number:116708692
Device Description: Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.IntraVu Scope is a m Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.IntraVu Scope is a miniaturized, sterile, single-use, disposable scope for use with the IntraVu Tablet reusable video processing unit.
Catalog Number
IV-ASY-1060
Brand Name
IntraVu Scope 60
Version/Model Number
IV-ASY-1060
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
af6dde3f-c232-4deb-9ee6-daffeeac1cdd
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |