Duns Number:305682023
Device Description: Ambu IOM Corkscrew Needle 747 For EEG or EP monitoring during surgery. Disposable, with 6 Ambu IOM Corkscrew Needle 747 For EEG or EP monitoring during surgery. Disposable, with 6 lead wire colours (red, black, blue, yellow, white and green) Min. order is 24 pcs. = 1 box
Catalog Number
74715-60/24
Brand Name
Ambu Subdermal CorkscrewSingle Patient Probes
Version/Model Number
74715-60/24
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
-
Product Code
GXZ
Product Code Name
Electrode, Needle
Public Device Record Key
f07c3e9c-7fbc-4e8b-b604-48b5d486162d
Public Version Date
July 31, 2018
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
05707480107612
Quantity per Package
48
Contains DI Package
05707480107605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |