Duns Number:002348191
Device Description: SureBlock(R) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose and Sharps Sa SureBlock(R) Spinal Anesthesia Kit with 0.75% Bupivacaine and 8.25% Dextrose and Sharps Safety Features
Catalog Number
ASA-25090-SBS
Brand Name
ARROW
Version/Model Number
IPN922606
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
K911260,K911260
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
48247218-9f96-4c3e-9811-333bebcb854b
Public Version Date
August 06, 2021
Public Version Number
1
DI Record Publish Date
July 29, 2021
Package DI Number
20801902202028
Quantity per Package
5
Contains DI Package
10801902202021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |