XeroGel Nasal/Epistaxis 8 Pack

GUDID 10857326005540

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.

ENTELLUS MEDICAL, INC.

ENT space-occupying dressing, animal-derived
Primary Device ID10857326005540
NIH Device Record Key34d05dc8-e5b5-4d39-bb36-12245bd8e056
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeroGel Nasal/Epistaxis 8 Pack
Version Model NumberXG-108
Company DUNS017283879
Company NameENTELLUS MEDICAL, INC.
Device Count8
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857326005543 [Primary]
GS110857326005540 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-18
Device Publish Date2020-09-10

Devices Manufactured by ENTELLUS MEDICAL, INC.

00850002250237 - TGS2023-07-07 Universal Headrest
00850002250244 - TGS2023-07-07 Universal Headrest Mounting Arm
00850002250251 - TGS2023-07-07 Universal Headrest Adapter A
00850002250268 - TGS2023-07-07 Universal Headrest Adapter B
00850002250275 - TGS2023-07-07 Universal Headrest Adapter C
00857326005567 - FocESS2023-07-07 HD Wireless Camera
00857326005581 - Portable Red LED Light Source2023-07-07 LED light source, red
00857326005536 - XeroGel2023-07-07 Nasal Epistaxis 2 Pack

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