Duns Number:116708692
Device Description: Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.MIDAScope™ is a mini Kit containing 60mm Scope and 60mm Cannula, 60mm Trocar, and Stopcock.MIDAScope™ is a miniaturized, sterile, single-use, disposable scope for use with the MIDASystem™ reusable video processing unit.
Catalog Number
IV-ASY-0800
Brand Name
MIDAScope™ - 60 and Introducer Kit
Version/Model Number
IV-ASY-0800
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 25, 2019
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
0f5ea283-a646-4601-a0d5-e3013c2e5f69
Public Version Date
March 27, 2020
Public Version Number
2
DI Record Publish Date
January 18, 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 |