FDA.reportPublic FDA data

NA

Primary DI
00681490195331
Brand
NA
Company
MEDTRONIC XOMED, INC.
Model
9124115
Device description
SEPTAL BUTTON 9124115 TAMI
Published
2017-03-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFBBUTTON, NASAL SEPTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFBButton, Nasal SeptalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781529000SEPTAL BUTTONXomed, Inc.1978-10-17LFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490195331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490195331006814901953316814901953310681490195331

GMDN Terms#

Term, Definition table
TermDefinition
Nasal septal buttonA device that is implanted to occlude a perforation in the nasal septum. It typically consists of a central post and two flanged ends. The device is inserted into a nostril, one leaf is folded and placed through the septum perforation, grasped through the opposite nostril and secured closing the perforation. It is used to improve nasal respiration.

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
00763000886721N/AMEDTRONIC XOMED, INC.LFB2025-06-23
00763000886738N/AMEDTRONIC XOMED, INC.LFB2025-06-23
14063107102254Nasal Septal ButtonBoston Medical Products, Inc.LFB2022-09-29
34063107102258Nasal Septal ButtonBoston Medical Products, Inc.LFB2022-09-29
00385640065207SUMMIT MEDICALSummit Medical, Inc.LFB2021-06-18
00385640065214SUMMIT MEDICALSummit Medical, Inc.LFB2021-06-18
00385640065221SUMMIT MEDICALSummit Medical, Inc.LFB2021-06-18
10385640065204SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065211SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
10385640065228SUMMIT MEDICALSUMMIT MEDICAL, INC.LFB2021-06-18
00813307013013InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00813307013082InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002101InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002118InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002125InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002132InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002149InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002156InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002163InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002170InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002187InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00848253002194InHealth Technologies; Blom-SingerFreudenberg Medical, LLCLFB2020-05-13
00763000035686N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000035693N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00763000036119N/AMEDTRONIC XOMED, INC.LFB2020-04-19
00681490041935NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490041942NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195317NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195348NAMEDTRONIC XOMED, INC.LFB2017-03-11
00818501020010Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2017-01-03