FDA.reportPublic FDA data

EpiDisc TM Perf Patch Kit

Primary DI
08033549790752
Brand
EpiDisc TM Perf Patch Kit
Company
Anika Therapeutics, Inc.
Model
653-160
Catalog number
1417151
Device description
EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
Published
2018-02-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033549790752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033549790752080335497907528033549790752

GMDN Terms#

Term, Definition table
TermDefinition
Tympanic membrane prosthesisA device intended for the repair or replacement of the membrana tympani of the middle ear typically implanted during ear/nose/throat (ENT) surgery. It is made of synthetic polymer material.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807613393
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817337000364NanoFx FURS-41012026-05-21
00817337000616Hyalomatrix60002322026-02-22
00817337000418Integrity Implant60001132026-01-05
00817337000425Integrity Implant60001142025-09-19
00866142000007Hydrelle685-0152014-09-30
08033549790738Epifilm Otologic653-20014170002018-02-19
08033549790745Epidisc 2pk Otologic 8mm653-30014171002018-02-19
08033549790769Merogel Injectable640-023CFN 15180002016-09-24
08033549790974Epifilm Otologic653-20014170002018-11-08
08033549790981Epidisc 2pk Otologic 8mm653-30014171002018-11-08
08033549790998EpiDisc TM Perf Patch Kit653-16014171512018-11-08
08033549791117MEROGEL 2pk 4x4cm65114115170022024-04-18
08033549791124MEROGEL 1PK 4x4cm65114015170002024-04-18
08033549791063Epifilm Otologic653-20014170002022-02-04
08033549790714Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022018-02-19
08033549790721Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002018-02-19
08033549790776MeroGel Otologic Packing 1x5cm651-14215171002018-02-19
08033549790950Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022020-01-15
08033549790967Merogel Nasal Dressing/Sinus Stent &Otologic Packing 4x4cm651-14015170002020-01-15
08033549791001MeroGel Otologic Packing 1x5cm651-14215171002020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCKHJ2026-05-07
00810235030853Prolaryn PlusMERZ NORTH AMERICA, INC.KHJ2026-02-24
00850056665292ORCA Foam PowderOrca Products, LLCKHJ2025-09-30
00850056665223ORCA FoamOrca Products, LLCKHJ2025-04-07
00850056665247ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665216ORCA FoamOrca Products, LLCKHJ2025-04-07
10850056665244ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665193ORCA Foam Orca Products, LLCKHJ2025-02-25
00850056665100ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665124ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665148ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00827002602854BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10827002602851BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10860008294347ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665001ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665025ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294333ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294357ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294388ORCA FoamOrca Products, LLCKHJ2023-09-15
10860003109974ORCA FoamOrca Products, LLCKHJ2022-02-24
10860003109981ORCA FoamOrca Products, LLCKHJ2022-02-24
10860008294309ORCA FoamOrca Products, LLCKHJ2022-02-24
08033549791063Epifilm OtologicAnika Therapeutics, Inc.KHJ2022-02-04
04260293133076GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-28
04260293133106GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133144GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133175GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133199GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133083GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133069GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-03-21