RealGUIDE Z3D KIT, Empty Tray

GUDID 08050038833226

3DIEMME SRL

Device sterilization/disinfection container, reusable
Primary Device ID08050038833226
NIH Device Record Key057405ac-701a-4b0b-a7bb-d43433b62df9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRealGUIDE Z3D KIT, Empty Tray
Version Model Number3DM00632ZUS
Company DUNS857172105
Company Name3DIEMME SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108050038833226 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-18
Device Publish Date2026-03-10

Devices Manufactured by 3DIEMME SRL

08050038833226 - RealGUIDE Z3D KIT, Empty Tray 2026-03-18
08050038833226 - RealGUIDE Z3D KIT, Empty Tray 2026-03-18
08050038834407 - RealGUIDE Z3D Surgical Kit2026-03-18
18050038834411 - RealGUIDE Sleeve2026-03-18
18050038834428 - RealGUIDE Sleeve2026-03-18
18050038834435 - RealGUIDE Sleeve2026-03-18
18050038834442 - RealGUIDE Sleeve2026-03-18
18050038834459 - RealGUIDE Sleeve2026-03-18
18050038834466 - RealGUIDE Sleeve2026-03-18

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