FDA.reportPublic FDA data

MirrorMe3D Nose Model - Baseline

Primary DI
00860008704177
Brand
MirrorMe3D Nose Model - Baseline
Company
Mirrorme3d, LLC
Model
MNMB
Device description
Patient-specific, partial face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Published
2022-10-03
Public version status
Update
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212981000MirrorMe3D Modeling SystemMirrorme3D, LLC2022-04-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008704177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008704177008600087041778600087041770860008704177

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060396278
Device count
1
DM exempt
true
Serial number
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
00860008704184MirrorMe3D Nose Model - SimulationMNMS2022-10-03
00860009784925Flap Marking TemplateMFFT2023-03-17
00860009784901GuideMTPG2023-02-16
00860009784918TemplateMOST2023-02-16
00196852129638TemplateMOST2022-10-03
00196852441754GuideMTPG2022-10-03
00860008704191Splint LT KitMSTL2022-10-03

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