FDA.reportPublic FDA data

ST

Primary DI
04580036673554
Brand
ST
Company
TAKAYAMA INSTRUMENTS INC.
Model
ST-L1
Catalog number
ST-L1
Device description
Sterilization Tray Large Hospital Size (10x17x1.5in)
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04580036673554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580036673554045800366735544580036673554

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
707948014
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580036672748KamiyamaK-101-1K-101-12025-06-26
04580036672755KamiyamaK-101-2K-101-22025-06-26
04580036672762KamiyamaK-102-1K-102-12025-06-26
04580036672779KamiyamaK-102-2K-102-22025-06-26
04580036672786KamiyamaK-103K-1032025-06-26
04580036672793KamiyamaK-104K-1042025-06-26
04580036672809KamiyamaK-110-1K-110-12025-06-26
04580036672816KamiyamaK-110-2K-110-22025-06-26
04580036672823KamiyamaK-111-1K-111-12025-06-26
04580036672830KamiyamaK-111-2K-111-22025-06-26
04580036672847KamiyamaK-3030K-30302025-06-26
04580036672854KamiyamaK-3010K-30102025-06-26
04580036672861KamiyamaK-203K-2032025-06-26
04580036672878KamiyamaK-1030K-10302025-06-26
04580036672885KamiyamaK-2030K-20302025-06-26
04580036672892KamiyamaK-2010K-20102025-06-26
04580036672908KamiyamaKTP-120KTP-1202025-06-26
04580036672915KamiyamaKTP-230KTP-2302025-06-26
04580036672922KamiyamaKTP-340KTP-3402025-06-26
04580036672939KamiyamaKTP-1520KTP-15202025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
07630894802973APTUSMedartis AGFSM2023-02-24
07630894802980APTUSMedartis AGFSM2023-02-24
07630894802997APTUSMedartis AGFSM2023-02-24
07630894803208APTUSMedartis AGFSM2023-02-24
07630894803215APTUSMedartis AGFSM2023-02-24
07630894803222APTUSMedartis AGFSM2023-02-24
07630894803246APTUSMedartis AGFSM2023-02-24
07630894803260APTUSMedartis AGFSM2023-02-24
07630894803307APTUSMedartis AGFSM2023-02-24
07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24