Duns Number:692666613
Device Description: This device is designed to be used with the endoscope holder "Point Setter" manufactured b This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.
Catalog Number
-
Brand Name
Universal 10-15mm pediatric
Version/Model Number
PS-BU-046
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
9a8f9032-4073-4c97-a5f4-4b2b6e02b7e2
Public Version Date
March 13, 2019
Public Version Number
2
DI Record Publish Date
February 06, 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 |