EpiDisc TM Perf Patch Kit 1417151

GUDID 08033549790998

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 ID08033549790998
NIH Device Record Key5f790052-f591-40ff-a83c-cfdd33b1a104
Commercial Distribution Discontinuation2025-06-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEpiDisc TM Perf Patch Kit
Version Model Number653-160
Catalog Number1417151
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 Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033549790998 [Primary]

FDA Product Code

KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-06-12
Device Publish Date2018-11-08

On-Brand Devices [EpiDisc TM Perf Patch Kit]

08033549791032EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of t
08033549790998EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of t
08033549790752EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of t

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