Duns Number:529249095
Catalog Number
-
Brand Name
Friendship Medical
Version/Model Number
NES-D2-1500/0.6
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
K072276,K072276
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
ba5644b1-4062-41c6-b94a-e45f530d236e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 05, 2016
Package DI Number
26955739010067
Quantity per Package
12
Contains DI Package
16955739010060
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. | 111 |