FDA.reportPublic FDA data

Splint LT Kit

Primary DI
00860008704191
Brand
Splint LT Kit
Company
Mirrorme3d, LLC
Model
MSTL
Device description
Patient specific, 3D printed, single use postoperative nasal splints to control edema based a patient’s treatment plan. RX only, non-diagnostic.
Published
2022-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00860008704191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008704191008600087041918600087041910860008704191

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060396278
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008704139Full Face Baseline ModelFFB2022-10-03
00860008704146Full Face Sim ModelFFS2022-10-03
00860008704153Baseline Rhinoplasty ModelMRCB2022-10-03
00860008704160Treatment Plan Rhinoplasty ModelMRCS2022-10-03
00860008704177MirrorMe3D Nose Model - BaselineMNMB2022-10-03
00860008704184MirrorMe3D Nose Model - SimulationMNMS2022-10-03
00860009784925Flap Marking TemplateMFFT2023-03-17
00860009784901GuideMTPG2023-02-16
00860009784918TemplateMOST2023-02-16
00196852129638TemplateMOST2022-10-03
00196852441754GuideMTPG2022-10-03

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