Kirwan

GUDID 20841019107403

Disposable Monopolar Suction Coagulator with Resectoscope Pin, 8" (20cm) 10 Fr

KIRWAN SURGICAL PRODUCTS LLC

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

• Primary Device ID: 20841019107403
• NIH Device Record Key: 3d89be3a-f4a6-4deb-b2c1-e00cbe9b9182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan
• Version Model Number: 30-5201
• 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: kprario@ksp.com

Device Dimensions

• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019107409 [Primary]
GS1	10841019107406 [Package]; Contains: 00841019107409; Package: [10 Units]; In Commercial Distribution
GS1	20841019107403 [Package]; Contains: 00841019107409; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895337

FDA Product Code

• HAM: Apparatus, Electrosurgical

Sterilization

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

[20841019107403]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-05-04

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