Duns Number:151772415
Device Description: CORRIDOR PILOT,2-LAMP,SOUNDER
Catalog Number
-
Brand Name
CORRIDOR PILOT,2-LAMP,SOUNDER
Version/Model Number
7785C
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
75722438-bdab-419b-b38d-616600a14608
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 792 |