FDA.reportPublic FDA data

SegWAY

Primary DI
00857356008729
Brand
SegWAY
Company
TRICE MEDICAL, INC.
Model
T400-064
Device description
SegWAY Instrument Set, Upper, ECTR and Lower
Published
2023-03-02
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
00857356008729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857356008729008573560087298573560087290857356008729

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009452895
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857356008767Tenex 2nd Generation MicroTip, TXL, 3.0 WLT600-030T600-0302025-03-06
00857356008774Tenex 2nd Generation MicroTip, TXL+, 2.5 WLT600-025T600-0252025-03-06
00857356008781Tenex 2nd Generation MicroTip, TXS, 2.0 WLT600-020T600-0202025-03-06
00857356008798Tenex 2nd Generation MicroTip, TXS+, 1.3 WLT600-013T600-0132025-03-06
00857356008842Tenex 2nd Generation ConsoleT600-001T600-0012025-03-06
00857356008859Tenex 2nd Generation Fuse Set3-10-05293-10-05292025-03-06
00861578000386mi-probeT900-011T900-0152018-04-10
10861578000376mi-eye Procedure Kit 5 packT900-0052017-11-10
00857356008026mi-eye 2T200-0102022-12-09
00857356008118mi-eye 2T215-1202022-12-09
00857356008309advansor-tfT500-0102023-03-02
00857356008156SegWAY ECTR-dT400-0232022-12-08
00857356008064mi-tablet 2T200-0202019-04-03
00861578000331mi-eye 2 95mmT200-0952017-06-09
00861578000348Trice Tablet 2 T200-0012017-06-09
00861578000355Trice Tablet 2 T200-001R2017-06-29
00861578000362mi-eye 2 160mmT200-1602017-09-20
00861578000379mi-eye Procedure KitT900-0012017-11-10
00857356008224mi-tablet 3T300-0012022-12-08
00857356008231mi-eye 3T300-0952022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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