Duns Number:831375089
Device Description: Disposable Fiber Optic Laryngoscope Handle, Medium LED, Sterile
Catalog Number
6292
Brand Name
PremierPro
Version/Model Number
6292
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
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
8a13ab90-3511-45da-9724-b7ffbe69cca3
Public Version Date
September 11, 2020
Public Version Number
1
DI Record Publish Date
September 03, 2020
Package DI Number
10818566019438
Quantity per Package
20
Contains DI Package
00818566019431
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |