FDA.reportPublic FDA data

BiValve Nasal Splint Thin

Primary DI
00385640000031
Brand
BiValve Nasal Splint Thin
Company
Summit Medical, Inc.
Model
SP-27000
Catalog number
SP-27000
Published
2016-08-09
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
EPPSplint, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPPSplint, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385640000038PackageGS16In Commercial Distribution
00385640000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038564000003810385640000038
00385640000031003856400000313856400000310385640000031

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 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

Contacts#

Phone, Email table
PhoneEmail
888-229-2875customerservice@summitmedicalusa.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640072403Quintess®16572026-05-13
00385640072410Quintess®16582026-05-13
00385640091794INSTRUSAFEIN-2020-77532026-05-13
00385640091800INSTRUSAFEIN-2020-78032026-05-13
00385640091817INSTRUSAFEIN-2020-77512026-05-13
00385640091824INSTRUSAFEIN-2020-77932026-05-13
00385640091831INSTRUSAFEIN-2020-77042026-05-13
00385640091848INSTRUSAFEIN-2020-72672026-05-13
00385640091855INSTRUSAFEIN-2550-05-EN-0622026-05-13
00385640091862INSTRUSAFEIN-2550-05-EN-0632026-05-13
00385640091879INSTRUSAFEIN-2550-05-EN-0642026-05-13
00385640091886INSTRUSAFEIN-2550-05-EN-0652026-05-13
00385640091893INSTRUSAFEIN-2600-04-EN-0852026-05-13
00385640091909INSTRUSAFEIN-2020-76362026-05-13
00385640091916INSTRUSAFEIN-2020-76942026-05-13
00385640091923INSTRUSAFEIN-2020-77962026-05-13
00385640091930INSTRUSAFEIN-2020-78852026-05-13
00385640091947INSTRUSAFEIN-2020-78272026-05-13
00385640091954INSTRUSAFEIN-2020-78302026-05-13
00385640091961INSTRUSAFEIN-2020-78292026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381810255External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-28
04250381823668Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823675Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823682Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823699External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823705External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823712External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823729Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823736Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823743Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823750Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823767Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381809945External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809969External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809976External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809990External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810019External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810057External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810071External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810088External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810101External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810125External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810194External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810217External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810231External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849828External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849835External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849859External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381851029Set external aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381856338Equipment box for external nasal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-09