Hydrelle

GUDID 00866142000007

Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel

Anika Therapeutics, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 00866142000007
• NIH Device Record Key: 0f226487-989f-4591-9628-e12ef86b12f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrelle
• Version Model Number: 685-015
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866142000007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050033

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-30

Devices Manufactured by Anika Therapeutics, Inc.

• 08033549790738 - Epifilm Otologic: 2025-06-12 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na
• 08033549790745 - Epidisc 2pk Otologic 8mm: 2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin
• 08033549790752 - EpiDisc TM Perf Patch Kit: 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
• 08033549790769 - Merogel Injectable: 2025-06-12 MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to c
• 08033549790974 - Epifilm Otologic: 2025-06-12 Epifilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the na
• 08033549790981 - Epidisc 2pk Otologic 8mm: 2025-06-12 EpiDisc Otologic Lamina is used as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healin
• 08033549790998 - EpiDisc TM Perf Patch Kit: 2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
• 00817337000319 - Deployment Skid Cannula Access Tool: 2024-05-23 Reusable non-rigid cannula access tool