LOSPA&LOSPA IS Surgical Instruments

GUDID 08806373878022

T-HANDLE

Corentec Co., Ltd

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 08806373878022
• NIH Device Record Key: 5fe10421-a4e2-47f0-91f5-697710bc6255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOSPA&LOSPA IS Surgical Instruments
• Version Model Number: SI.ZH1.0002
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• 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

Customer Support Contacts

• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com
• Phone: +82269374902
• Email: ra@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373878022 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

[08806373878022]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

Devices Manufactured by Corentec Co., Ltd

• 08800017299013 - LOSPA Surgical Instruments: 2025-12-03 Distal Cutting Guide L Phase2
• 08800017299020 - LOSPA Surgical Instruments: 2025-12-03 AP Sizer Phase2
• 08800068959348 - LOSPA Surgical Instruments: 2025-12-03 Tibial Drill #3~#9
• 08800068959355 - LOSPA Surgical Instruments: 2025-12-03 Tibial Drill #11~
• 08800068959362 - LOSPA Surgical Instruments: 2025-12-03 Angel Wing
• 08800068959379 - LOSPA Surgical Instruments: 2025-12-03 PS Chisel
• 08800068959386 - LOSPA Surgical Instruments: 2025-12-03 Bone File
• 08800068959393 - LOSPA Surgical Instruments: 2025-12-03 Baseplate Headed Pin