Kirwan

GUDID 20841019116030

Disposable Bipolar Pencil, 23 Gauge, Tapered Tip, Blunt, Blue Insulation, Geuder Logo (Special)

KIRWAN SURGICAL PRODUCTS LLC

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

• Primary Device ID: 20841019116030
• NIH Device Record Key: 970f1117-5317-4e85-a17b-009cbbc96480
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan
• Version Model Number: 14-5009S
• 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	00841019116036 [Primary]
GS1	10841019116033 [Package]; Contains: 00841019116036; Package: [10 Units]; In Commercial Distribution
GS1	20841019116030 [Package]; Contains: 00841019116036; Package: [50 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

[20841019116030]

Radiation 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: 2018-01-26

On-Brand Devices [Kirwan]

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• 00841019117606: Reusable Bipolar Forceps Angled Down 45 Deg., 6mm After Bend, 6mm Exposed Tip Length (Special)
• 00841019117934: Reusable Monopolar Electrode, Debakey Style (Special)
• 00841019103517: Reusable Bimanual Aspiration Handpiece
• 00841019103500: Reusable 23 Gauge Bimanual Irrigation Handpiece
• 00841019103494: Reusable Bimanual Irrigation Handpiece
• 00841019103487: Reusable I/A Handpiece, Curved Shaft
• 00841019103470: Reusable I/A Handpiece, Curved 90 Degree Angle Tip
• 00841019103463: Reusable Irrigation or Aspiration Handpiece (For Use With Disposable Cannulas)
• 00841019103456: Reusable I/A Handpiece, Binkhorst Tip
• 00841019103449: Reusable I/A Handpiece, Curved 45 Degree Angle Tip
• 00841019103432: Reusable I/A Handpiece, Straight Tip
• 00841019117828: Reusable Bipolar Forceps, Tips Angled Up 45 Degrees (Special)
• 00841019117811: Reusable Bipolar Forceps, Laser Mark Cup "P AU", Tips Angled Up 45 Degrees (Special)
• 00841019117798: Reusable Bipolar Forceps, 5mm Exposed Tip Length, Tip Angled Up 45 Degrees (Special)
• 00841019117750: Reusable Bipolar Forceps 3 3/8" Working Length (Special)
• 00841019117712: Reusable Bipolar Forceps, Decreased Closing Pressure (200g +/-50) (Special)
• 00841019117705: Reusable Bipolar Forceps, Decreased Closing Pressure (200g +/-50) (Special)
• 00841019117699: Reusable Bipolar Forceps, Decreased Closing Pressure (200g +/-50) (Special)
• 00841019117682: Reusable Bipolar Forceps, Decreased Closing Pressure (200g +/-50) (Special)
• 00841019117804: Reusable Bipolar Forceps, 35mm Working Length (Special)
• 00841019117767: Reusable Bipolar Forceps 6 1/4" Working Length (Special)
• 00841019117743: Reusable Bipolar Forceps 1.5mm Tips (Special)
• 00841019117835: 8" Reusable Bipolar Forceps, 2.0mm Tips, Mark "7" on the Cup (Special)
• 00841019117781: Reusable Bipolar Forceps Cup Marked "Dr.Z" (Special)
• 00841019117774: Reusable Bipolar Forceps Mark "Dr. Z" on Cup (Special)
• 00841019117873: Reusable Bipolar Forceps 3.0mm Tip, Mark "AS30" on Cup (Special)
• 00841019117972: 25 ft. Reusable Silicone Bipolar Cord (Special)
• 00841019117866: Reusable Bipolar Forceps with 0.5mm Tips, Add Insulation, Add Stops, Adjust Closing Pressure to
• 00841019117910: Reusable Bipolar Forceps 5" Total Length (Special)
• 00841019117859: Reusable Bipolar Forceps, 6" WL Angled Down 20 Degrees, Tips Angled Up 45 Degrees at 3mm (Specia
• 00841019118047: Reusable Bipolar Pencil, 18Ga. (Special)
• 00841019117897: Reusable Bipolar Forceps 2.0mm Tip, 4" Working Length (Special)
• 00841019117880: Reusable Bipolar Forceps 3.0mm Tip, Mark "AS30" on Cup (Special)
• 00841019103586: Reusable Bipolar Forceps 0.5mm Tips, Tips Angled Down 45 Degrees (Special)
• 00841019103579: Reusable Bipolar Forceps 0.5mm Tips, Tips Angled Up 45 Degrees (Special)
• 00841019117996: Reusable Bipolar Forceps with 0.3mm Tips (Special)
• 00841019117989: Reusable Bipolar Forceps with Tips Angled Up 45 Degrees (Special)
• 00841019117927: Reusable Bipolar Forceps, 5mm Exposed Tip Length, Tips Angled Up 45 Degrees, Cup Marked "AU05" (
• 00841019106570: Reusable Bipolar Forceps with Tips Angled Up 45 Degrees (Special)
• 00841019117965: Reusable Bipolar Forceps with Tips Angled Up 22 Degrees (Special)
• 00841019118160: Reusable Bipolar Forceps, 0.5mm Tip & Add Irrigation (Special)
• 00841019118153: Reusable Bipolar Forceps, 1.5mm Tip & Add Irrigation (Special)
• 00841019118238: Reusable Bipolar Forceps, Decreased Working Length to 1", Add Irrigation & 0.5mm Tips (Special)
• 00841019118252: Reusable Silicone Bipolar Cord with European Bladed Forceps Connector for Wolf/Martin Generator
• 00841019118245: Reusable Bipolar Forceps, 3mm Exposed Tip Length, Angled Up 45 Degrees (Special)
• 00841019118429: Reusable Bipolar Forceps, Mark "HLC-11-19" on Cup (Special)
• 00841019118283: Reusable Bipolar Forceps, Insulation, Handswitching, Stops (Special)
• 00841019118290: Reusable Bipolar Forceps, Tips Angled Up 90 Degrees (Special)
• 00841019118337: Reusable Bipolar Forceps with 5mm Exposed Tip Length, Mark "AU05" on the Cup (Special)