Duns Number:839138955
Device Description: Long Pencil Nose Knot Pusher, 5mm X 33cm
Catalog Number
-
Brand Name
AED
Version/Model Number
KP1617
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
-
Product Code
NWV
Product Code Name
Laparoscopic accessories, gynecologic
Public Device Record Key
914ec492-776b-4d7b-aafc-6d66fd7c5ba6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 21, 2017
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 | 579 |
2 | A medical device with a moderate to high risk that requires special controls. | 6418 |