Flex H/A®

Primary DI
00763000034412
Brand
Flex H/A®
Company
MEDTRONIC XOMED, INC.
Model
0520
Device description
PROSTHESIS 0520 FLEX H/A OFF TOTAL 4MM
Published
2021-11-07
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
ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904239000SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHESMicrobio-Medics, Inc.1991-06-21ETA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000034412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000034412007630000344127630000344120763000034412

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
Length7Millimeter

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
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
00763000033385HA/C Polycel® Brackmann TotalMEDTRONIC XOMED, INC.ETA2024-05-12
00763000034832Sheehy HA/C Polycel® P.O.P.MEDTRONIC XOMED, INC.ETA2024-05-12
00763000034849Sheehy HA/C Polycel® T.O.P.MEDTRONIC XOMED, INC.ETA2024-05-12
00763000036591Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036607Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036614Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036621Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036638Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12