Duns Number:041674552
Device Description: Disposable Macintosh F/O Blade, Size 0
Catalog Number
Not Applicable
Brand Name
MedSource Disposable Laryngoscope Blade
Version/Model Number
MS-46210
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
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
9f09b15f-571d-4ad0-aca7-60ad88801dd1
Public Version Date
July 19, 2021
Public Version Number
1
DI Record Publish Date
July 09, 2021
Package DI Number
00840155401914
Quantity per Package
100
Contains DI Package
00840155401907
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |