Duns Number:022721133
Device Description: FO MILLER 00/PEDIATRIC SINGLE USE DISPOSABLE LARYNGOSCOPE SYSTEM-STERILE
Catalog Number
S01-6039.C.61016.C
Brand Name
IntuBrite Sterile
Version/Model Number
S01-6039.C.61016.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
a30d70c0-655c-4284-880d-f70d3fff0aad
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2018
Package DI Number
10607411969383
Quantity per Package
5
Contains DI Package
00607411969386
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 |