Duns Number:300238441
Device Description: Synea Handpiece Attachment
Catalog Number
-
Brand Name
WK-86 LT
Version/Model Number
30027001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2018
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDA
Product Code Name
Enteroscope And Accessories
Public Device Record Key
7d2ff0c0-0bb9-4bf3-adb4-c300019d9903
Public Version Date
August 09, 2019
Public Version Number
3
DI Record Publish Date
August 31, 2018
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 | 343 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |