FDA.reportPublic FDA data

Big Easy® Piston

Primary DI
00763000036614
Brand
Big Easy® Piston
Company
MEDTRONIC XOMED, INC.
Model
1156613
Device description
PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
Published
2024-05-12
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
ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002897000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002897000TITANIUM MIDDLE EAR PROSTHESESXomed, Inc.2000-10-11ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000036614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000036614007630000366147630000366140763000036614

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
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
00763000945817ApexCut EM187BL4012EM2026-10-24
00763000945824ApexCut EM187BL4040EM2026-10-24
00763000945831ApexCut EM187BL4060EM2026-10-24
00763000945848ApexCut EM187BL2975EM2026-10-24
00763000945855ApexCut EM187BL3590EM2026-10-24
00763000957858ApexCut EM187BL4000LEM2026-10-24
20763000089652SLIDE-ON® ENDOSHEATH®2245012018-07-07
00681490038997N/A13565012017-09-10
00681490040488NA14160002015-06-23
00681490040518NA14160302015-06-23
20681490040604N/A14190202017-10-13
20681490041762NA15140002016-04-30
20681490042424NA15325002015-06-25
20681490069315NA31185302016-04-17
20681490138622BRIDGEMASTER®6003022017-09-09
20681490138646BOOMERANG®6005002017-09-09
20643169232000Alar ™150002017-10-13
00643169553019XPS®1898200TLO2016-05-01
00643169564749VISAO®3334800LO2016-05-01
20613994394525SLIDE-ON®4444012016-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056138805446AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-28
08056138803497AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-26
08056138804630AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804647AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804654AudioprosthesisAUDIO TECHNOLOGIES SRLETA2026-10-26
08056138804852AudioprosthesisAUDIO 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
08056138805439AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-26
08056138800014AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-23
08056138800021AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138800137AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805453AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805484AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805491AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805507AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
08056138805514AudioprosthesisAUDIO TECHNOLOGIES SRLETB2026-10-22
00844505010269TITANIUM/FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2026-02-03
00844505014526GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014533GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014540GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014502TITANIUM PISTONGrace Medical, Inc.ETB2025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-09-18
00844505014489ECLIPSE PISTONGrace Medical, Inc.ETB2025-08-05
00844505014519TITANIUM PISTONGrace Medical, Inc.ETB2025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05