Duns Number:053146767
Device Description: Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding th Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 60 mm.
Catalog Number
-
Brand Name
SH 77-3 Oropharyngeal Airway
Version/Model Number
SH 77-3
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
39755e29-17e5-4c76-9dae-1da9be44425d
Public Version Date
March 25, 2019
Public Version Number
1
DI Record Publish Date
March 16, 2019
Package DI Number
M996SH7735
Quantity per Package
50
Contains DI Package
M996SH7730
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Polybag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |