FDA.reportPublic FDA data

SegWAY

Primary DI
00857356008750
Brand
SegWAY
Company
TRICE MEDICAL, INC.
Model
200-6020
Device description
Knife Guide Assy, ECUTR, 2.7mm
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
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
00857356008750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857356008750008573560087508573560087500857356008750

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
10888857415928Brainlab Compatible K2M Navigation InstrumentsVB Spine LLCLXH2025-09-09
10888857431096ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857431102ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857431119ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857431126ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857431133ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857431140ALEUTIAN Interbody SystemsVB Spine LLCLXH2023-12-01
10888857421097OZARK Cervical Plate SystemVB Spine LLCLXH2023-06-27
10888857421103OZARK Cervical Plate SystemVB Spine LLCLXH2023-06-27
10888857422179OZARK Cervical Plate SystemVB Spine LLCLXH2023-06-27
10888857431386EVEREST Spinal SystemVB Spine LLCLXH2023-03-29
10888857432215EVEREST Spinal SystemVB Spine LLCLXH2023-03-23
10888857432550YUKON OCT Spinal SystemVB Spine LLCLXH2023-02-02
10888857422322ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422339ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422346ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422353ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422360ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422377ALEUTIAN Interbody SystemsVB Spine LLCLXH2022-10-12
10888857422759EVEREST Spinal SystemVB Spine LLCLXH2022-08-09
10888857422766EVEREST Spinal SystemVB Spine LLCLXH2022-08-09
10888857430921EVEREST Spinal SystemVB Spine LLCLXH2022-08-09
10888857421646EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857421653EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857421660EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857421776EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857421813EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857423541EVEREST Spinal SystemVB Spine LLCLXH2022-08-06
10888857431461CASCADIA Interbody SystemVB Spine LLCLXH2022-05-31
10888857415904Brainlab Compatible K2M Navigation InstrumentsVB Spine LLCLXH2022-04-26