FDA.reportPublic FDA data

Austin / Polycel®

Primary DI
00763000035396
Brand
Austin / Polycel®
Company
MEDTRONIC XOMED, INC.
Model
1156305
Device description
PROSTHESIS 1156305 AUSTIN TOTAL 3MM HD
Published
2021-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBMPOROUS POLYETHYLENE OSSICULAR REPLACEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBMPorous Polyethylene Ossicular ReplacementEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823441000AUSTIN MODIFIED TOTAL OSSICULAR REPLACETreace Medical, Inc.1982-12-03LBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000035396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000035396007630000353967630000353960763000035396

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, totalA sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and 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 polymers.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000309480Causse/PolycelMEDTRONIC XOMED, INC.LBM2025-06-23
00763000913700Austin/PolycelMEDTRONIC XOMED, INC.LBM2025-06-23
00763000035402Fisch / Polycel®MEDTRONIC XOMED, INC.LBM2021-11-07
00763000035440Austin / Polycel®MEDTRONIC XOMED, INC.LBM2021-11-07
00763000035471Moretz / Polycel®MEDTRONIC XOMED, INC.LBM2021-11-07
00763000035488Causse / Polycel®MEDTRONIC XOMED, INC.LBM2021-11-07
00681490035491FischMEDTRONIC XOMED, INC.LBM2015-06-23
00681490035712AustinMEDTRONIC XOMED, INC.LBM2015-06-23
00681490035767MortezMEDTRONIC XOMED, INC.LBM2015-06-23
00681490035477AustinMEDTRONIC XOMED, INC.LBM2015-06-22
00681490035484FischMEDTRONIC XOMED, INC.LBM2015-06-22
00681490035507NAMEDTRONIC XOMED, INC.LBM2015-06-22
00681490035743MortezMEDTRONIC XOMED, INC.LBM2015-06-22
00681490035750CausseMEDTRONIC XOMED, INC.LBM2015-06-22