FDA.reportPublic FDA data

RealGUIDE Z3D KIT, Empty Tray

Primary DI
08050038833226
Brand
RealGUIDE Z3D KIT, Empty Tray
Company
3DIEMME SRL
Model
3DM00632ZUS
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050038833226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050038833226080500388332268050038833226

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
857172105
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08050038831116RealGUIDE IMPLANT MOUNT3DM00606ZIM47US2022-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30
07613327652765TPXSTRYKER CORPORATIONFSM2026-03-25
07613327631852RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631869RPSSTRYKER CORPORATIONFSM2025-10-10
07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03