BiPad Hand Activated Disposable Bipolar Electrocautery Cord Y-Connector BP105CY

GUDID 00860001107098

Y-connector for use with the BiPad Hand activated disposable bipolar electrocautery cord model BP105-C

Bipad, Inc.

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

• Primary Device ID: 00860001107098
• NIH Device Record Key: 71a098e6-44e2-4fb5-b8fd-b98eb2febd3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiPad Hand Activated Disposable Bipolar Electrocautery Cord Y-Connector
• Version Model Number: BP105-CY
• Catalog Number: BP105CY
• 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	00860001107098 [Package]; Contains: 00860003991800; Package: shipping box [1 Units]; In Commercial Distribution
GS1	00860003991800 [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: 2020-10-27
• Device Publish Date: 2020-10-19

Devices Manufactured by Bipad, Inc.

• 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: 2020-10-27Y-connector for use with the BiPad Hand activated disposable bipolar electrocautery cord model BP105-C
• 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)