Duns Number:801380697
Device Description: PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring C PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
Catalog Number
-
Brand Name
PosiSep X2 0.8" x 2.3"
Version/Model Number
9210615
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
4eb84958-c1de-4015-a21a-67c507526302
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 2021
Package DI Number
00858439001910
Quantity per Package
5
Contains DI Package
00858439001903
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 |