FDA.reportPublic FDA data

3DIEMME RealGUIDE

Primary DI
08050038830034
Brand
3DIEMME RealGUIDE
Company
3DIEMME SRL
Model
RealGUIDE START
Device description
3D diagnosis and communication module
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K173041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1730410003DIEMME RealGUIDE3Diemme , Ltd.2018-12-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038830034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038830034080500388300348050038830034

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390317073353info@3diemme.it

Regulatory Flags#

DUNS number
857172105
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08050038833226RealGUIDE Z3D KIT, Empty Tray 3DM00632ZUS2026-03-10
08050038834407RealGUIDE Z3D Surgical Kit3DM0070ZUS2026-03-10
18050038834411RealGUIDE Sleeve3DM00605AZTC40.102026-03-10
18050038834428RealGUIDE Sleeve3DM00605AZTC50.102026-03-10
18050038834435RealGUIDE Sleeve3DM00605AZTC60.102026-03-10
18050038834442RealGUIDE Sleeve3DM00605NEOEG.102026-03-10
18050038834459RealGUIDE Sleeve3DM00605NEOGM.102026-03-10
18050038834466RealGUIDE Sleeve3DM00605NEOGMNRW.102026-03-10
18050038834473RealGUIDE Sleeve3DM00605NEOGMWD.102026-03-10
18050038834541RealGUIDE Sleeve3DM00605NEOEGNRW.102026-03-10
18050038834558RealGUIDE Sleeve3DM00605CAMPL33.102026-03-10
18050038834565RealGUIDE Sleeve3DM00605CAMPL38.102026-03-10
18050038834572RealGUIDE Sleeve3DM00605CAMPL43.102026-03-10
18050038834589RealGUIDE Sleeve3DM00605CAMPL50.102026-03-10
18050038834596RealGUIDE Sleeve3DM00605STRSL.102026-03-10
08050038832021RealGUIDE Surgical Kit3DM00700US2025-08-07
08050038832144RealGUIDE™ Z3D KIT, Empty Tray 3DM00632ZUS2024-12-06
08050038833165AZURE TAPERED BONE LEVEL GUIDED SURGICAL TRAY, EMPTY 3DM00632TBLTRAY2024-12-06
08050038831093RealGUIDE IMPLANT MOUNT3DM00606ZIM31US2022-07-01
08050038831109RealGUIDE IMPLANT MOUNT3DM00606ZIM35US2022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20