Duns Number:089055867
Device Description: PROBE 3700-003 DISSECT 90 DEG TIP 19.7
Catalog Number
-
Brand Name
Edoscopic Dissection Probe
Version/Model Number
3700-003
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945633
Product Code
GWG
Product Code Name
ENDOSCOPE, NEUROLOGICAL
Public Device Record Key
5345e402-d2f2-4f41-a552-feb026e42a43
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 2016
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |