BENCOX Bipolar Cup System

GUDID 08806373869440

BENCOX Bipolar Cup 53mm-Insert

Corentec Co., Ltd

Metallic femoral head prosthesis

• Primary Device ID: 08806373869440
• NIH Device Record Key: cebdd7da-3e4e-4f42-b273-d20b90b169ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENCOX Bipolar Cup System
• Version Model Number: H2.A51.0053-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373869440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112019

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-17
• Device Publish Date: 2020-04-09

On-Brand Devices [BENCOX Bipolar Cup System]

• 08806373869280: BENCOX Bipolar Cup 60mm
• 08806373869273: BENCOX Bipolar Cup 57mm
• 08806373869266: BENCOX Bipolar Cup 56mm
• 08806373869259: BENCOX Bipolar Cup 55mm
• 08806373869242: BENCOX Bipolar Cup 54mm
• 08806373869235: BENCOX Bipolar Cup 53mm
• 08806373869228: BENCOX Bipolar Cup 52mm
• 08806373869211: BENCOX Bipolar Cup 51mm
• 08806373869204: BENCOX Bipolar Cup 50mm
• 08806373869198: BENCOX Bipolar Cup 49mm
• 08806373869181: BENCOX Bipolar Cup 48mm
• 08806373869174: BENCOX Bipolar Cup 47mm
• 08806373869167: BENCOX Bipolar Cup 46mm
• 08806373869150: BENCOX Bipolar Cup 45mm
• 08806373869143: BENCOX Bipolar Cup 44mm
• 08806373869136: BENCOX Bipolar Cup 43mm
• 08806373869129: BENCOX Bipolar Cup 42mm
• 08806373869112: BENCOX Bipolar Cup 41mm
• 08806373869105: BENCOX Bipolar Cup 40mm
• 08806373869099: BENCOX Bipolar Cup 39mm
• 08806373869068: BENCOX Bipolar Cup 38mm
• 08806373869518: PE Ring 28mm
• 08806373869501: PE Ring 22mm
• 08806373869495: BENCOX Bipolar Cup 60mm-Insert
• 08806373869488: BENCOX Bipolar Cup 57mm-Insert
• 08806373869471: BENCOX Bipolar Cup 56mm-Insert
• 08806373869464: BENCOX Bipolar Cup 55mm-Insert
• 08806373869457: BENCOX Bipolar Cup 54mm-Insert
• 08806373869440: BENCOX Bipolar Cup 53mm-Insert
• 08806373869433: BENCOX Bipolar Cup 52mm-Insert
• 08806373869426: BENCOX Bipolar Cup 51mm-Insert
• 08806373869419: BENCOX Bipolar Cup 50mm-Insert
• 08806373869402: BENCOX Bipolar Cup 49mm-Insert
• 08806373869396: BENCOX Bipolar Cup 48mm-Insert
• 08806373869389: BENCOX Bipolar Cup 47mm-Insert
• 08806373869372: BENCOX Bipolar Cup 46mm-Insert
• 08806373869365: BENCOX Bipolar Cup 45mm-Insert
• 08806373869358: BENCOX Bipolar Cup 44mm-Insert
• 08806373869341: BENCOX Bipolar Cup 43mm-Insert
• 08806373869327: BENCOX Bipolar Cup 41mm-Insert
• 08806373869310: BENCOX Bipolar Cup 40mm-Insert
• 08806373869303: BENCOX Bipolar Cup 39mm-Insert
• 08806373869297: BENCOX Bipolar Cup 38mm-Insert
• 08806373869334: BENCOX Bipolar Cup 42mm-Insert