Hydrelle

GUDID 00866142000007

Cross-Linked Hyaluronic Acid and Lidocaine Injectable Gel

Anika Therapeutics, Inc.

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID00866142000007
NIH Device Record Key0f226487-989f-4591-9628-e12ef86b12f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydrelle
Version Model Number685-015
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866142000007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-30

Devices Manufactured by Anika Therapeutics, Inc.

08033549790738 - Epifilm Otologic2025-06-12 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 8mm2025-06-12 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 Kit2025-06-12 EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
08033549790769 - Merogel Injectable2025-06-12 MEROGEL Injectable is a bioresorbable nasal dressing and sinus stent and otologic gel designed to help control bleeding and to c
08033549790974 - Epifilm Otologic2025-06-12 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 8mm2025-06-12 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 Kit2025-06-12 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 Tool2024-05-23 Reusable non-rigid cannula access tool

Trademark Results [Hydrelle]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYDRELLE
HYDRELLE
78765400 3687564 Dead/Cancelled
Anika Therapeutics, Inc.
2005-12-02
HYDRELLE
HYDRELLE
73353341 1258138 Dead/Cancelled
Pfizer Inc.
1982-03-08

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