Duns Number:079375431
Catalog Number
181A089
Brand Name
Halyard
Version/Model Number
96539
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 17, 2018
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
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
ea21bf32-1b89-4882-8138-98db4b46594e
Public Version Date
December 13, 2021
Public Version Number
6
DI Record Publish Date
January 31, 2016
Package DI Number
30680651965395
Quantity per Package
10
Contains DI Package
10680651965391
Package Discontinue Date
April 17, 2018
Package Status
Not 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 |