Duns Number:692666613
Device Description: This device is designed to be used with the endoscope holder "UniARM" manufactured by Mita This device is designed to be used with the endoscope holder "UniARM" manufactured by Mitaka Kohki Co., Ltd.
Catalog Number
-
Brand Name
Micro Manipulator UMP
Version/Model Number
UMP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090792
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
d6120621-0f9c-4215-8836-4f02adac76f7
Public Version Date
March 11, 2019
Public Version Number
2
DI Record Publish Date
February 05, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |