Duns Number:079375431
Device Description: HALYARD* Polypectomy Snare
Catalog Number
60416
Brand Name
Halyard
Version/Model Number
92671
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
Yes
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
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
6dff5a75-8e7c-4eac-90d6-b660bb929ce9
Public Version Date
November 16, 2018
Public Version Number
3
DI Record Publish Date
July 06, 2016
Package DI Number
30680651926716
Quantity per Package
10
Contains DI Package
10680651926712
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |