FDA.reportPublic FDA data

Mortez

Primary DI
00681490035422
Brand
Mortez
Company
MEDTRONIC XOMED, INC.
Model
1156297
Device description
PROSTHESIS 1156297 MORETZ MALLEUS STRUT
Published
2015-07-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBNREPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBNReplacement, Total Ossicular, Prosthesis, Porous, PolyethyleneEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822367000TOTALTreace Medical, Inc.1982-09-07LBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490035422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490035422006814900354226814900354220681490035422

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
Device Size Text, specify0
Length5Millimeter

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
00763000821777NIM EssenceNIMEID0602026-06-07
00763000821784NIM EssenceNIMEID0652026-06-07
00763000821791NIM EssenceNIMEID0702026-06-07
00763000821807NIM EssenceNIMEID0752026-06-07
00763000821814NIM EssenceNIMEID0802026-06-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000913687Brackmann/PolycelMEDTRONIC XOMED, INC.LBN2025-06-23
00763000035372Moretz / Polycel®MEDTRONIC XOMED, INC.LBN2021-11-07
00763000035389Brackmann / Polycel®MEDTRONIC XOMED, INC.LBN2021-11-07
00681490035408Fischer Sprandel IIMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035415MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035439MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035446MortezMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035453BrackmannMEDTRONIC XOMED, INC.LBN2015-07-01
00681490035460MoretzMEDTRONIC XOMED, INC.LBN2015-07-01