Duns Number:693273427
Device Description: 22G x 5"(127mm)Clear plastic hub
Catalog Number
-
Brand Name
Curved Tip Needle
Version/Model Number
SBB127-22
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"
-
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
K961151,K961151
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
58e7bf14-c8e2-46a3-9398-e0087ac2134e
Public Version Date
June 03, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
14526737170340
Quantity per Package
10
Contains DI Package
04526737170343
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 94 |