Codman Y-Connector, 4-prong device only, unpackaged BP105-CY4

GUDID 00860003991817

4 pole Y connector

Bipad, Inc.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00860003991817
• NIH Device Record Key: 955db5ec-c194-4c44-a0e3-6a2e8d52786a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Codman Y-Connector, 4-prong device only, unpackaged
• Version Model Number: BP105-CY4
• Catalog Number: BP105-CY4
• Company DUNS: 117114183
• Company Name: Bipad, Inc.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003991817 [Package]; Contains: 00860003991824; Package: Shipping [1 Units]; In Commercial Distribution
GS1	00860003991824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201833

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

Devices Manufactured by Bipad, Inc.

• 00860003991817 - Codman Y-Connector, 4-prong device only, unpackaged: 2021-03-084 pole Y connector
• 00860003991817 - Codman Y-Connector, 4-prong device only, unpackaged: 2021-03-08 4 pole Y connector
• 10860001107033 - BiPad Hand Activated Disposable Bipolar Electrocautery Cord: 2020-10-27 BiPad Hand Activated Disposable Bipolar Electrocautery Cord Model BP105-C (Codman version)
• 00860001107098 - BiPad Hand Activated Disposable Bipolar Electrocautery Cord Y-Connector: 2020-10-27 Y-connector for use with the BiPad Hand activated disposable bipolar electrocautery cord model BP105-C
• 00860001107043 - BiPad Hand Activated Disposable Bipolar Electrocautery Cord: 2020-10-27 BiPad Hand Activated Disposable Bipolar Electrocautery Cord, Model BP105-M (Medtronic version)