BENCOX Total Hip System Instrumentation

GUDID 08800068961419

Instrumentation - Shell Trial 50mm(C+)

Corentec Co., Ltd

Acetabulum prosthesis trial, prefabricated, reusable

• Primary Device ID: 08800068961419
• NIH Device Record Key: bcc3782d-eab7-4024-9946-93c59eb02571
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENCOX Total Hip System Instrumentation
• Version Model Number: HA.01D.1050
• Company DUNS: 688739895
• Company Name: Corentec Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com
• Phone: +82415857114
• Email: sungwon.yang@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800068961419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220468

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

[08800068961419]

Moist Heat or Steam Sterilization

[08800068961419]

Moist Heat or Steam Sterilization

[08800068961419]

Moist Heat or Steam Sterilization

[08800068961419]

Moist Heat or Steam Sterilization

[08800068961419]

Moist Heat or Steam Sterilization

[08800068961419]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [BENCOX Total Hip System Instrumentation]

• 08800068961419: Instrumentation - Shell Trial 50mm(C+)
• 08800068961440: Anteversion Guide
• 08800017200446: Mirabo Cup Impactor