Duns Number:693273427
Device Description: 22G x 2"(51mm)Plastic hubWith wings, calibrations
Catalog Number
-
Brand Name
Tuohy Epidural Needle
Version/Model Number
2-2150-22
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
K961152,K961152
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
7e90a219-997b-42f6-bb12-fe9fdc419f45
Public Version Date
June 03, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
14526737171033
Quantity per Package
10
Contains DI Package
04526737171036
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 |