Duns Number:002348191
Device Description: RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 1,2
Catalog Number
5446M
Brand Name
RUSCH
Version/Model Number
IPN915574
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
a6561152-72ac-43a2-a54a-6c5346ce8c58
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
54026704712545
Quantity per Package
12
Contains DI Package
14026704712547
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 |