Kirwan (Distributor Gyrus ACMI)

GUDID 00841019108765

Bipolar Semkin Forceps, Non-Stick Reusable 0.7mm Tips, Length 5.5"

KIRWAN SURGICAL PRODUCTS LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841019108765
• NIH Device Record Key: f1aef540-2cac-41b7-8352-5c66a2dab873
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kirwan (Distributor Gyrus ACMI)
• Version Model Number: 13-1505
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-834-9500
• Email: kprario@ksp.com

Device Dimensions

• Length: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019108765 [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

[00841019108765]

Moist Heat or Steam 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: 2016-06-26

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• 00841019108758: Bipolar Adson Forceps, Non-Stick Insulated, Reusable 1mm Tips, Length 5"
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• 00841019108734: Bipolar Iris Forceps, Non-Stick Curved Tips, Reusable 0.4mm Tips, Length 3.5"
• 00841019108727: Bipolar Iris Forceps, Non-Stick Straight Tips, Reusable 0.4mm Tips, Length 3.5"