Duns Number:418415568
Device Description: Disposable Subdermal Needle, corkscrew 1.2m twisted wire 12pairs & PC
Catalog Number
-
Brand Name
Ambu
Version/Model Number
74812/60-12
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
dc27848b-567b-4ae7-b126-49cd87b6dcb7
Public Version Date
July 12, 2022
Public Version Number
1
DI Record Publish Date
July 04, 2022
Package DI Number
08718375869239
Quantity per Package
12
Contains DI Package
08718375869215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfbox
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 429 |