DEVICE: RELIEVA SCOUT (10705031238039)
Device Identifier (DI) Information
RELIEVA SCOUT
SCT0624MFS
In Commercial Distribution
SCT0624MFS
ACCLARENT, INC.
SCT0624MFS
In Commercial Distribution
SCT0624MFS
ACCLARENT, INC.
RELIEVA SCOUT MULTI-SINUS DILATION SYSTEM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12699 | Nasal haemostatic balloon |
A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LRC | INSTRUMENT, ENT MANUAL SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153341 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
009acb9d-32c7-429b-b04c-22f998287a44
November 06, 2020
6
October 01, 2016
November 06, 2020
6
October 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20705031238036 | 5 | 10705031238039 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)775-2789
xx@xx.xx +1(650)687-5888
xx@xx.xx
xx@xx.xx +1(650)687-5888
xx@xx.xx