Duns Number:002065670
Device Description: Blade, Laryngoscope, GreenLine F/O, Macintosh English Channel, American Profile, Size 3.5 Blade, Laryngoscope, GreenLine F/O, Macintosh English Channel, American Profile, Size 3.5 Adult (145mm)
Catalog Number
GL-381-3.5
Brand Name
AincA®
Version/Model Number
GL-381-3.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
3549d1ce-a896-4f79-872d-cc14d4197288
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 561 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |