MeroGel Otologic Packing 1x5cm 1517100

GUDID 08033549791001

MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding and act as an adjunct to aid in the natural healing process.

Anika Therapeutics, Inc.

Intranasal splint, biodegradable

• Primary Device ID: 08033549791001
• NIH Device Record Key: 6f371715-4764-4ad6-92db-84cbbe8991a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeroGel Otologic Packing 1x5cm
• Version Model Number: 651-142
• Catalog Number: 1517100
• 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 < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place T < or = 40 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033549790776 [Previous]
GS1	08033549791001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001148

FDA Product Code

• KHJ: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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: 2020-01-23
• Device Publish Date: 2020-01-15

On-Brand Devices [MeroGel Otologic Packing 1x5cm]

• 08033549791001: MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal
• 08033549790776: MeroGel Otologic Packing is a space occupying dressing and/or stent intended to separate mucosal