Duns Number:022721133
Device Description: Stubby SINGLE USE DISPOSABLE LARYNGOSCOPE HANDLE-STERILE
Catalog Number
S01-2017.C
Brand Name
IntuBrite Sterile
Version/Model Number
S01-2017.C
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
0c7dac39-6a5d-4f88-a32e-269cbeeccf11
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2018
Package DI Number
10607411966368
Quantity per Package
10
Contains DI Package
00607411966361
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |