Duns Number:002348191
Device Description: SureBlock(R) Spinal Anesthesia Kit
Catalog Number
ASK-25090-BIDMC
Brand Name
ARROW
Version/Model Number
IPN922622
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
3b2c84c7-1c30-4d20-a4d2-d530c6ce1393
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 2021
Package DI Number
20801902202189
Quantity per Package
5
Contains DI Package
10801902202182
Package Discontinue Date
-
Package Status
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 |