Duns Number:002348191
Device Description: ARROW(R) FlexBlock(TM) Continuous Peripheral Nerve Block Set
Catalog Number
FB-19605-SNS
Brand Name
ARROW
Version/Model Number
IPN046018
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
2d754d2b-5cb0-44b5-9ae7-221b1a206611
Public Version Date
November 04, 2020
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
30801902069147
Quantity per Package
10
Contains DI Package
00801902069146
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 |