FDA.reportPublic FDA data

SegWAY

Primary DI
00857356008583
Brand
SegWAY
Company
TRICE MEDICAL, INC.
Model
200-6040
Device description
Knife Guide Assy, ECUTR, 4mm
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857356008583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857356008583008573560085838573560085830857356008583

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
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
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
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191692Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191708Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191722Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191739Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191777Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191920Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191937Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191968Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191999Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00888867532236Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532243Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532250Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532267Arthrex®ARTHREX, INC.LXH2026-07-31
00888867532274Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544819Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544826Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544833Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544840Arthrex®ARTHREX, INC.LXH2026-07-31
00888867544857Arthrex®ARTHREX, INC.LXH2026-07-31