Kirwan (Distributor Nidek Co., Ltd.)

GUDID 20841019108684

20mm Disposable Bipolar Cable, 12 ft. (3.6m)

KIRWAN SURGICAL PRODUCTS LLC

Electrical-only medical device connection cable, single-use

• Primary Device ID: 20841019108684
• NIH Device Record Key: de589a48-0c14-4658-a176-986e491865c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan (Distributor Nidek Co., Ltd.)
• Version Model Number: 18241-M991
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 12 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019108680 [Primary]
GS1	10841019108687 [Package]; Contains: 00841019108680; Package: [10 Units]; In Commercial Distribution
GS1	20841019108684 [Package]; Contains: 00841019108680; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831236

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[20841019108684]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-26

Devices Manufactured by KIRWAN SURGICAL PRODUCTS LLC

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• 00841019122389 - Kirwan: 2024-12-02 Reusable Bipolar Forceps with 2.0mm Tips (Special)
• 00841019122396 - Kirwan: 2024-11-14 Reusable Bipolar Forceps with 5mm Exposed Tip and “AS05” Marked on the Cup (Special)
• 00841019122525 - Kirwan: 2024-11-04 Reusable Bipolar Forceps with 0.75mm Tips (Special)
• 00841019122372 - Kirwan: 2024-10-24 Reusable Bipolar Forceps with 0.3mm Tips (Special)
• 00841019122365 - Kirwan: 2024-10-21 Reusable Bipolar Cord with EAU Bladed Connector (Special)
• 00841019122358 - Kirwan: 2024-10-14 Reusable Bipolar Forceps with 2.0mm Tips (Special)