Duns Number:361092450
Device Description: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK
Catalog Number
RSP0616MFSNZ
Brand Name
RELIEVA SPINPLUS NAV
Version/Model Number
RSP0616MFSNZ
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
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
K171687
Product Code
LRC
Product Code Name
INSTRUMENT, ENT MANUAL SURGICAL
Public Device Record Key
2df4ced3-16be-48f4-aa78-71b2fc4ab31a
Public Version Date
January 22, 2020
Public Version Number
6
DI Record Publish Date
February 18, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |