FDA.reportPublic FDA data

TESSYS® Sterilization Tray for Instruments

Primary DI
04250337119265
Brand
TESSYS® Sterilization Tray for Instruments
Company
Joimax GmbH
Model
TIT502550-T1
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250337119265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337119265042503371192654250337119265

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118985J-Needle Navi WL 120, trocar, 11 GJINTJT1230102026-10-28
04250337119661Endo-Kerrison ShaftEKS245555402026-10-28
04250337120674Inner Drill Reamer 4.0 mm, cannulatedDRC2440242026-10-28
04250337120681Outer Drill, bluntDRC227341B2026-10-28
04250337120698Outer Drill, crownDRC227341C2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableDRC244024R2026-10-28
04250337120872Camera Head Ocular for Camsource® DuoCSD4K01CO2026-10-28
04250337120988Optic CouplerCSD4K01COV2026-10-28
04250337120995Fibre optic cableCSLC02502026-10-28
04250337121008Fiber Optic Cable Adapter joimax/WolfCSLC0250.L12026-10-28
04250337121817Endo-Kerrison ShaftEKS246550402026-10-28
04250337121879CuretteDEC2645122026-10-28
04250337121992DissectorJDA264519C2026-10-28
04250337122104iLESSYS® Delta Access TrayTDT502550DL-12026-10-28
04250337122111iLESSYS® Delta Resection TrayTDT502550DL-22026-10-28
04250337106784Percusys® PlusJMPP0535MSJMPP0535MS2020-01-03
04250337106791Percusys® PlusJMPP0540MSJMPP0540MS2020-01-03
04250337106807Percusys® PlusJMPP0545MSJMPP0545MS2020-01-03
04250337106814Percusys® PlusJMPP0550MSJMPP0550MS2020-01-03
04250337106821Percusys® PlusJMPP0635MSJMPP0635MS2020-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337122104iLESSYS® Delta Access TrayJoimax GmbHFSM2026-10-28
04250337122111iLESSYS® Delta Resection TrayJoimax GmbHFSM2026-10-28
06954454000564COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000571COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000588COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000595COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454000601COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001202COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
06954454001271COTISENHuanghua Promisee Dental Co., Ltd.FSM2026-10-28
M739223000700Nav Instruments General TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739223000800Nav Instruments Pedicle Screws TrayCAPTIVA SPINE, INC.FSM2026-10-28
M739253001012Discectomy Prep TrayCAPTIVA SPINE, INC.FSM2026-10-28
00889024702660OsseoFitZimmer, Inc.FSM2026-10-27
00889024702677OsseoFitZimmer, Inc.FSM2026-10-27
00889024702684OsseoFitZimmer, Inc.FSM2026-10-27
00889024702691OsseoFitZimmer, Inc.FSM2026-10-27
00889024702707OsseoFitZimmer, Inc.FSM2026-10-27
00889024702714OsseoFitZimmer, Inc.FSM2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMFBrainlab SEFSM2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)Brainlab SEFSM2026-10-27
04250337118497Vaporgrip® Bipo Sterilization TrayJoimax GmbHFSM2026-10-27
04250337119272TESSYS® Sterilization Tray for InstrumentsJoimax GmbHFSM2026-10-27
00889024699854IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699861IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699878IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699885IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699892IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699908IDENTITY HumeralZimmer, Inc.FSM2026-10-21
00889024699915Comprehensive HumeralZimmer, Inc.FSM2026-10-21
00889024699922Identity HumeralZimmer, Inc.FSM2026-10-21