Duns Number:603420183
Device Description: miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.
Catalog Number
080130
Brand Name
miniRUMEL™
Version/Model Number
080130
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 09, 2020
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"
-
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
b6f875de-bbf8-4069-8df5-4cfc8d7c1f08
Public Version Date
October 29, 2021
Public Version Number
5
DI Record Publish Date
July 03, 2020
Package DI Number
10850200006589
Quantity per Package
12
Contains DI Package
00850200006582
Package Discontinue Date
October 09, 2020
Package Status
Not in Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |