FDA.reportPublic FDA data

OSSEOUSExternal Thermoplastic Splint

Primary DI
08906039311501
Brand
OSSEOUSExternal Thermoplastic Splint
Company
EON MEDITECH PRIVATE LIMITED
Model
E5150M
Device description
External Thermoplastic Nasal Splint splinting of nasal dorsum after Rhinoplastly and providing support of nasal Septal structure.
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
08906039312386PackageGS1225In Commercial Distribution
08906039312416PackageGS110In Commercial Distribution
08906039311501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906039312386089060393123868906039312386
08906039312416089060393124168906039312416
08906039311501089060393115018906039311501

GMDN Terms#

Term, Definition table
TermDefinition
External nasal splintA rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.9Millimeter
Length38Millimeter
Width40Millimeter
Width60Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13

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