FDA.reportPublic FDA data

SUMMIT MEDICAL

Primary DI
00385640065207
Brand
SUMMIT MEDICAL
Company
Summit Medical, Inc.
Model
SP-78100
Catalog number
SP-78100
Published
2021-06-18
Public version status
Update
Distribution status
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
K982667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982667000MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.1998-11-24LFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385640065204PackageGS11In Commercial Distribution
00385640065207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564006520410385640065204
00385640065207003856400652073856400652070385640065207

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8882292875customerservice@summitmedicalusa.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640095174INSTRUSAFEIN-2020-80252026-10-20
00385640095181INSTRUSAFEIN-2020-82952026-10-20
00385640095198INSTRUSAFEIN-2020-82282026-10-20
00385640095204INSTRUSAFEIN-2020-82732026-10-20
00385640095167INSTRUSAFEIN-2020-77352026-10-16
00385640095082INSTRUSAFEIN-2020-82852026-10-15
00385640095099INSTRUSAFEIN-2020-81252026-10-15
00385640095105INSTRUSAFEIN-2020-82152026-10-15
00385640095112INSTRUSAFEIN-2020-79102026-10-15
00385640095129INSTRUSAFEIN-2020-82582026-10-15
00385640095136INSTRUSAFEIN-2020-80112026-10-15
00385640095143INSTRUSAFEIN-2300-05-EN-1522026-10-15
00385640095150INSTRUSAFEIN-2300-05-EN-1532026-10-15
00385640095051INSTRUSAFEIN-2020-81722026-10-14
00385640095068INSTRUSAFEIN-2020-82842026-10-14
00385640095075INSTRUSAFEIN-2020-81232026-10-14
00385640095044INSTRUSAFEIN-2020-82382026-10-13
00385640094887INSTRUSAFEIN-2020-81602026-10-09
00385640094894INSTRUSAFEIN-2020-74472026-10-09
00385640094870INSTRUSAFEIN-2020-81062026-10-08

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
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
00681490195331NAMEDTRONIC XOMED, INC.LFB2017-03-11
00681490195348NAMEDTRONIC XOMED, INC.LFB2017-03-11
00818501020010Invotec Nasal Septal ButtonINVOTEC INTERNATIONAL, INC.LFB2017-01-03