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 ID: 10857326005540
• NIH Device Record Key: 34d05dc8-e5b5-4d39-bb36-12245bd8e056
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XeroGel Nasal/Epistaxis 8 Pack
• Version Model Number: XG-108
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857326005543 [Primary]
GS1	10857326005540 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113585

FDA Product Code

• LYA: Splint, Intranasal Septal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-18
• Device Publish Date: 2020-09-10

Devices Manufactured by ENTELLUS MEDICAL, INC.

• 00850002250237 - TGS: 2023-07-07 Universal Headrest
• 00850002250244 - TGS: 2023-07-07 Universal Headrest Mounting Arm
• 00850002250251 - TGS: 2023-07-07 Universal Headrest Adapter A
• 00850002250268 - TGS: 2023-07-07 Universal Headrest Adapter B
• 00850002250275 - TGS: 2023-07-07 Universal Headrest Adapter C
• 00857326005567 - FocESS: 2023-07-07 HD Wireless Camera
• 00857326005581 - Portable Red LED Light Source: 2023-07-07 LED light source, red
• 00857326005536 - XeroGel: 2023-07-07 Nasal Epistaxis 2 Pack