Duns Number:079375431
Device Description: HYHSURGPN,ON-Q-TBLOC,ECTUHY,-,2",5
Catalog Number
TBT03050ST
Brand Name
Halyard
Version/Model Number
40780
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K073187,K073187
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
04f268f2-36cd-4c6f-ac2d-2a9e0e9adf8e
Public Version Date
November 16, 2018
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
30680651407802
Quantity per Package
5
Contains DI Package
10680651407808
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 |