Epidisc 2pk Otologic 8mm 1417100

GUDID 08033549791025

EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Anika Therapeutics, Inc.

Tympanic membrane prosthesis

• Primary Device ID: 08033549791025
• NIH Device Record Key: 8a3d1298-492b-4a85-9a0a-765953f22c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epidisc 2pk Otologic 8mm
• Version Model Number: 653-300
• Catalog Number: 1417100
• 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, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place, < or = 40 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033549790981 [Previous]
GS1	08033549791025 [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

On-Brand Devices [Epidisc 2pk Otologic 8mm]

• 08033549791025: EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adju
• 08033549790981: EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adju
• 08033549790745: EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adju