Duns Number:801380697
Device Description: PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Ch PosiSep X devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X devices expand when hydrated providing separation between the sinus tissues.
Catalog Number
-
Brand Name
PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint
Version/Model Number
9210604
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
K120958,K122494,K120958,K122494
Product Code
EMX
Product Code Name
Balloon, Epistaxis
Public Device Record Key
c6319108-6164-45ea-a155-0a487d71787f
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
February 20, 2020
Package DI Number
00858439001378
Quantity per Package
5
Contains DI Package
00858439001361
Package Discontinue Date
-
Package Status
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 | 9 |
| U | Unclassified | 7 |