Duns Number:002348191
Device Description: EQUIPLED SET: STANDARD HANDLE+MAC 3,4,5
Catalog Number
5619
Brand Name
RUSCH
Version/Model Number
IPN915581
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
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
742380d5-ed6a-475b-b1b8-616546ee6c66
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
54026704712613
Quantity per Package
20
Contains DI Package
14026704712615
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |