Kirwan (Nidek)

GUDID 20841019116627

Disposable Bipolar Pencil 25 Gauge Straight

KIRWAN SURGICAL PRODUCTS LLC

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

• Primary Device ID: 20841019116627
• NIH Device Record Key: ed671e19-ef1c-4e55-9004-1b354b89a5ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan (Nidek)
• Version Model Number: 18241-0979
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019116623 [Primary]
GS1	10841019116620 [Package]; Contains: 00841019116623; Package: [5 Units]; In Commercial Distribution
GS1	20841019116627 [Package]; Contains: 00841019116623; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864402

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[20841019116627]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-17

On-Brand Devices [Kirwan (Nidek)]

• 20841019116627: Disposable Bipolar Pencil 25 Gauge Straight
• 20841019116610: Disposable Bipolar Pencil 23 Gauge Straight