Duns Number:329515725
Device Description: Hybrid needles (Stimulation + ultrasound) 22G x 35 mm
Catalog Number
EHB035-22
Brand Name
Temena
Version/Model Number
EHB035-22
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)
-
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
9af7b929-bcea-45ba-be67-d87a8e87ba51
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 21, 2017
Package DI Number
03700339706556
Quantity per Package
10
Contains DI Package
03700339716555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 144 |