Kirwan

GUDID 00841019107454

Reusable Monopolar Electrode 15" (38cm) Insulated, Spatula Tip

KIRWAN SURGICAL PRODUCTS LLC

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: 00841019107454
• NIH Device Record Key: 193f9f49-afa8-467f-a289-4b660e4ddf1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan
• Version Model Number: 30-6003
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 15 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019107454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895331

FDA Product Code

• JOS: Electrode, Electrosurgical

Sterilization

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

[00841019107454]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-04

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• 00841019117910: Reusable Bipolar Forceps 5" Total Length (Special)
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• 00841019117996: Reusable Bipolar Forceps with 0.3mm Tips (Special)
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• 00841019117927: Reusable Bipolar Forceps, 5mm Exposed Tip Length, Tips Angled Up 45 Degrees, Cup Marked "AU05" (
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