Duns Number:002348191
Device Description: SureBlock(TM) Spinal Anesthesia Kit
Catalog Number
ASK-25090-BIDMC
Brand Name
ARROW
Version/Model Number
IPN055746
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
Yes
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
e29cd8a9-f6c3-4402-8d98-5d6782d20027
Public Version Date
July 06, 2022
Public Version Number
6
DI Record Publish Date
August 19, 2019
Package DI Number
20801902158868
Quantity per Package
5
Contains DI Package
10801902158861
Package Discontinue Date
July 05, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |