Neuro-Tec / MD Resources

GUDID 10841019122683

Disposable Irrigation Bipolar Cord

KIRWAN SURGICAL PRODUCTS LLC

Electrical-only medical device connection cable, single-use

• Primary Device ID: 10841019122683
• NIH Device Record Key: ad7981a4-3045-4018-acd6-566dbae2b7d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro-Tec / MD Resources
• Version Model Number: 975-301BD
• Company DUNS: 046355210
• Company Name: KIRWAN SURGICAL PRODUCTS LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019122686 [Primary]
GS1	10841019122683 [Package]; Contains: 00841019122686; Package: [10 Units]; In Commercial Distribution
GS1	20841019122680 [Package]; Contains: 00841019122686; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992218

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2024-12-16
• Device Publish Date: 2024-12-07

Devices Manufactured by KIRWAN SURGICAL PRODUCTS LLC

• 00841019122808 - Kirwan: 2025-04-02 Reusable Bipolar Forceps, Irrigating, 55mm Working Length (Special)
• 00841019122754 - Kirwan: 2025-03-31 Reusable Bipolar Forceps with Irrigation and 75mm Working Length (Special)
• 00841019122761 - Kirwan: 2025-03-31 Reusable Bipolar Forceps with Irrigation and 95mm Working Length (Special)
• 00841019122778 - Kirwan: 2025-03-31 Reusable Bipolar Forceps ADD IRRIGATION, 115MM WORKING LENGTH (Special)
• 00841019122815 - Kirwan: 2025-03-31 Reusable Bipolar Forceps, Add Irrigation, 135mm Working Length (Special)
• 00841019122839 - Kirwan: 2025-03-31 Reusable Bipolar Forceps, "Dr. Z" Marked on Cup (Special)
• 00841019122846 - Kirwan: 2025-03-26 Reusable Bipolar Forceps with "AS00" Marked on the Cup (Special)
• 00841019122853 - Kirwan: 2025-03-20 Reusable Bipolar Forceps 0.25 MM TIP, STRAIGHT, 4 MM TIP EXPOSURE (Special)