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.

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• 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