Duns Number:002348191
Device Description: RUSCH GREENLITE SU MTL BLADE MILL 1
Catalog Number
004550001
Brand Name
RUSCH
Version/Model Number
IPN048379
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2019
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
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
5e3caaaf-4628-44cd-9173-f64e4e5ffabd
Public Version Date
December 16, 2019
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
44026715626001
Quantity per Package
10
Contains DI Package
34026714626005
Package Discontinue Date
February 21, 2019
Package Status
Not 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 |