FDA.reportPublic FDA data

Goode

Primary DI
00763000870591
Brand
Goode
Company
MEDTRONIC XOMED, INC.
Model
1016035
Device description
VENT TUBE 1016035 5PK GOODE T FIRM 12MM
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETDTUBE, TYMPANOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151067000Ventilation (Tympanostomy) TubesMedtronic Xomed, Inc.2015-07-22ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000870595PackageGS15In Commercial Distribution
00763000870591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300087059520763000870595
00763000870591007630008705917630008705910763000870591

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

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
M6333816500JEDMEDJEDMED INSTRUMENT COMPANYETD2023-05-08
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00385640068659Summit MedicalSummit Medical, Inc.ETD2022-10-06
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00385640068697Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068703Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068710Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068727Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068734Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068741Summit MedicalSummit Medical, Inc.ETD2022-10-06
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00385640068765Summit MedicalSummit Medical, Inc.ETD2022-10-06
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00385640068826Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068833Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068840Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068857Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068864Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068871Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068888Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068895Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068901Summit MedicalSummit Medical, Inc.ETD2022-10-06