Duns Number:305682023
Device Description: Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile fro Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Catalog Number
512001000
Brand Name
aScope™ 4 RhinoLaryngo Intervention
Version/Model Number
512001000
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
-
Product Code
EOB
Product Code Name
Nasopharyngoscope (flexible or rigid)
Public Device Record Key
86b0853f-ae0b-4232-93e4-4ae813d9068a
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
September 06, 2019
Package DI Number
05707480136988
Quantity per Package
5
Contains DI Package
05707480136971
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 |