EpiDisc TM Perf Patch Kit 1417151

GUDID 08033549791032

EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.

Anika Therapeutics, Inc.

Tympanic membrane prosthesis

• Primary Device ID: 08033549791032
• NIH Device Record Key: 15883cb9-1478-41d3-8d40-b4ba73b76863
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiDisc TM Perf Patch Kit
• Version Model Number: 653-160
• Catalog Number: 1417151
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033549790998 [Previous]
GS1	08033549791032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982870

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

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