Duns Number:418415568
Device Description: Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 co Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 connector; OD 3.8mm x ID 3mm x 190mm sheath; 2m extension cable with DIN42802 connector
Catalog Number
-
Brand Name
Amendia
Version/Model Number
4014-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2021
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
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
8b84495e-34b6-4d73-82e3-537ae5717ef4
Public Version Date
December 15, 2021
Public Version Number
4
DI Record Publish Date
June 27, 2017
Package DI Number
08718375865347
Quantity per Package
1
Contains DI Package
08718375865293
Package Discontinue Date
December 14, 2021
Package Status
Not in Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 429 |