FDA.reportPublic FDA data

Audioprosthesis

Primary DI
08056138804852
Brand
Audioprosthesis
Company
AUDIO TECHNOLOGIES SRL
Model
TAP 07.63
Catalog number
TAP 07.63
Device description
Ti ADJUSTABLE TOTAL OTOSURGERY PROSTHESIS
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001142000AUDIO TECHNOLOGIES S:R.1Audio Technologies S.R.L.2000-06-23ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056138804852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056138804852080561388048528056138804852

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, partialA sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+390523778864info@audiotechnologies.it

Regulatory Flags#

DUNS number
459394425
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056138803497AudioprosthesisINCUS 07.32INCUS 07.322026-10-26
08056138804630AudioprosthesisTAP 07.55TAP 07.552026-10-26
08056138804647AudioprosthesisTAP 07.58TAP 07.582026-10-26
08056138804654AudioprosthesisTAP 07.58 SHTAP 07.58 SH2026-10-26
08056138804869AudioprosthesisTAP 07.63 SHTAP 07.63 SH2026-10-26
08056138805071AudioprosthesisTAP 07.67TAP 07.672026-10-26
08056138805088AudioprosthesisTAP 07.67 SHTAP 07.67 SH2026-10-26
08056138805095AudioprosthesisTAP 07.71TAP 07.712026-10-26
08056138805101AudioprosthesisTAP 07.71 SHTAP 07.71 SH2026-10-26
08056138805439AudioprosthesisTPL 07.44TPL 07.442026-10-26
08056138800014AudioprosthesisSPL 03.00.350SPL 03.00.3502026-10-23
08056138800021AudioprosthesisSPL 03.00.400SPL 03.00.4002026-10-22
08056138800137AudioprosthesisSPL 03.04.475SPL 03.04.4752026-10-22
08056138805453AudioprosthesisTPL 07.51TPL 07.512026-10-22
08056138805484AudioprosthesisTPL 07.73TPL 07.732026-10-22
08056138805491AudioprosthesisTPL 07.74TPL 07.742026-10-22
08056138805507AudioprosthesisTPL 07.75TPL 07.752026-10-22
08056138805514AudioprosthesisTPL 07.76TPL 07.762026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056138804630AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804647AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804654AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804869AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138805071AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138805088AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138805095AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138805101AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.ETA2025-07-17
00763000913489N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913526Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913540Causse/Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913564Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913571Causse/VincentMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913595Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913601Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913625N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913632N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913656N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913663SilversteinMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913717Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913724Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913731N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913762N/AMEDTRONIC XOMED, INC.ETA2025-06-23