Duns Number:609197785
Catalog Number
-
Brand Name
Clint Pharmaceuticals
Version/Model Number
ACL5SPS
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"
Yes
For Single-Use
Yes
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
K965017,K965017
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
25103c1d-fd39-4336-a325-6e34ed38f55b
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
January 13, 2017
Package DI Number
30351688077213
Quantity per Package
30
Contains DI Package
20351688077216
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |