Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm 1517000

GUDID 08033549790721

Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sinus and the middle ear/external ear canal as a space occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery, and in otologic packing, to act as an adjunct to aid in the natural healing process.

Anika Therapeutics, Inc.

Intranasal splint, biodegradable

• Primary Device ID: 08033549790721
• NIH Device Record Key: bbe2bc4f-3900-469c-a0ea-5a4447c5d266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm
• Version Model Number: 651-140
• Catalog Number: 1517000
• Company DUNS: 807613393
• Company Name: Anika Therapeutics, Inc.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, T ≤ 40 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033549790721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982731

FDA Product Code

• EMX: Balloon, Epistaxis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-12-21
• Device Publish Date: 2018-02-19

On-Brand Devices [Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm]

• 08033549790967: Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sinus and
• 08033549790721: Medtronic MeroGel Nasal Dressing/Sinus stent and Otologic Packing is used in the nasal/sinus and