Hyalomatrix

GUDID 00817337000616

Hyalomatrix 2.5 cm x 2.5 cm

Anika Therapeutics, Inc.

Synthetic wound matrix dressing

• Primary Device ID: 00817337000616
• NIH Device Record Key: e58a909d-dbfa-44d6-a0b2-6e1bea4eea70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyalomatrix
• Version Model Number: 6000232
• 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: true
• 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	00817337000616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073251

FDA Product Code

• QSZ: Absorbable Synthetic Wound Dressing

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: 2026-03-02
• Device Publish Date: 2026-02-22

Devices Manufactured by Anika Therapeutics, Inc.

• 00817337000616 - Hyalomatrix: 2026-03-02Hyalomatrix 2.5 cm x 2.5 cm
• 00817337000616 - Hyalomatrix: 2026-03-02 Hyalomatrix 2.5 cm x 2.5 cm
• 00817337000418 - Integrity Implant: 2026-01-13 Integrity Implant, 25mm x 60mm
• 00817337000425 - Integrity Implant: 2025-09-29 Integrity Implant, 40mm x 60mm
• 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