BENCOX Bipolar Cup System

GUDID 08806373869105

BENCOX Bipolar Cup 40mm

Corentec Co., Ltd

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 08806373869105
• NIH Device Record Key: 347eb485-3b4d-429e-898a-6e97998994fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENCOX Bipolar Cup System
• Version Model Number: H2.A51.0040
• 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
• 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
• 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
• Phone: +82415857114
• Email: sungwon.yang@corentec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806373869105 [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: 2019-11-20
• Device Publish Date: 2019-11-12

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