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
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
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