Duns Number:361092450
Device Description: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, F-70 SINUS GUIDE CATHETER TIP
Catalog Number
RSF70
Brand Name
RELIEVA SPIN
Version/Model Number
RSF70
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K111875,K111875
Product Code
LRC
Product Code Name
INSTRUMENT, ENT MANUAL SURGICAL
Public Device Record Key
44c25cb5-707e-40d0-ac9d-c14d8eae8936
Public Version Date
November 06, 2020
Public Version Number
6
DI Record Publish Date
October 01, 2016
Package DI Number
20705031200583
Quantity per Package
5
Contains DI Package
10705031200586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |