Kirwan

GUDID 00841019108871

Non-Stick Disposable Bipolar Forceps 7 1/2" (19.1cm) Gerald Bayonet, Insulated, 1.0mm Tip

KIRWAN SURGICAL PRODUCTS LLC

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

• Primary Device ID: 00841019108871
• NIH Device Record Key: 736a2953-c7a0-45fb-9ee9-58f20409016f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan
• Version Model Number: 19-1103AUX
• 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: 7.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019108871 [Primary]
GS1	10841019108878 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900533

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00841019108871]

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: 2016-06-25

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