Duns Number:305682023
Device Description: Subdermal Corkscrew Length 2 m (79 inch), 4 x 6 colors
Catalog Number
74720-60/24
Brand Name
Ambu Subdermal CorkscrewSingle Patient Probes
Version/Model Number
74720-60/24
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
f1de39fe-4b21-4d48-90e4-8732315e5a48
Public Version Date
October 30, 2019
Public Version Number
3
DI Record Publish Date
July 30, 2018
Package DI Number
05707480129645
Quantity per Package
24
Contains DI Package
05707480129638
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 |