SegWAY

GUDID 00857356008453

Dilator, Reusable, SST

TRICE MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00857356008453
• NIH Device Record Key: 72cbf96a-f706-48ea-9436-df0aa32e6eed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SegWAY
• Version Model Number: 000-327
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857356008453 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

[00857356008453]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-03
• Device Publish Date: 2022-12-08

On-Brand Devices [SegWAY]

• 00857356008583: Knife Guide Assy, ECUTR, 4mm
• 00857356008576: Ligament Probe, SST
• 00857356008569: Ligament Rasp, SST
• 00857356008552: Guide, Lower, ECUTR, 4mm
• 00857356008545: Guide, Upper, ECUTR, 4mm
• 00857356008538: Dilator-Elevator, Synovial, SS
• 00857356008521: SegWAY Knife Guide, Sm, RT, 2.7mm
• 00857356008514: Knife Guide, SS, Med, RT, 4mm
• 00857356008507: Knife Guide, SS, Sm, LT, 2.7mm
• 00857356008491: Knife Guide, SS, Med, LT, 4mm
• 00857356008484: Knife Guide, SS, Lge, 4mm
• 00857356008477: Instrument Case Lid
• 00857356008460: Instrument Case Base
• 00857356008453: Dilator, Reusable, SST
• 00857356008446: SegWAY Instrument Set, Upper and Lower
• 00857356008439: SegWAY Instrument Set, Upper, ECTR and Lower
• 00857356008422: SegWAY Instrument Set, Upper, ECTR-CUTR
• 00857356008750: Knife Guide Assy, ECUTR, 2.7mm
• 00857356008743: Guide, Lower, ECUTR, 7mm
• 00857356008736: Guide, Upper, ECUTR, 2.7mm
• 00857356008729: SegWAY Instrument Set, Upper, ECTR and Lower