Duns Number:002348191
Device Description: SureBlock(TM) Spinal Anesthesia Set
Catalog Number
ASA-24090-SS
Brand Name
ARROW
Version/Model Number
IPN040072
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
-
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
c532c644-5d47-4a26-96fe-7cd22fe11024
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902059933
Quantity per Package
5
Contains DI Package
00801902059932
Package Discontinue Date
December 16, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
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 |