Duns Number:305682023
Device Description: Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box
Catalog Number
414001000
Brand Name
aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use
Version/Model Number
414001000
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
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
00bfb55a-b4b4-4264-b8f2-092c08d546f0
Public Version Date
July 16, 2018
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
05707480133116
Quantity per Package
5
Contains DI Package
05707480133109
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 |