Duns Number:017283879
Device Description: XeroGel Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol ( XeroGel Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry pack. Upon placement, the pack absorbs fluids in the field and swells conforming to the mucosal tissue site surface to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.
Catalog Number
-
Brand Name
XeroGel Nasal/Epistaxis 8 Pack
Version/Model Number
XG-108
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
K113585,K113585
Product Code
EMX
Product Code Name
Balloon, Epistaxis
Public Device Record Key
34d05dc8-e5b5-4d39-bb36-12245bd8e056
Public Version Date
September 28, 2020
Public Version Number
2
DI Record Publish Date
September 10, 2020
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |