Kirwan

GUDID 00841019122044

Reusable Bipolar Forceps with Axial Bayonet, 8" Total Length, 7mm Exposed Tip Length, "NM03" Marked on the Cup, and Tips Like Spetzler Tips (Tip Ends Meet First) (Special)

KIRWAN SURGICAL PRODUCTS LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841019122044
• NIH Device Record Key: 7e85dc39-7f9c-40d5-9b32-a16079eeb4d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan
• Version Model Number: 12-1633AUS
• 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: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com
• Phone: 781-834-9500
• Email: mprario@ksp.com

Device Dimensions

• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch
• Length: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019122044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811820

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

[00841019122044]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-14
• Device Publish Date: 2024-06-06

On-Brand Devices [Kirwan]

• 00841019117941: Reusable Bipolar Forceps, 0.25mm Tip, 2.0mm Tip Exposure (Special)
• 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)