Axon

GUDID 00841019109281

8 1/2" Hardy Bayonet Forceps Insulated, with Stops, 0.5mm Tip

Axon Medical Inc

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: 00841019109281
• NIH Device Record Key: 359da95b-0003-465b-af47-2244150df090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axon
• Version Model Number: J1000
• Company DUNS: 111700451
• Company Name: Axon Medical Inc
• 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: 8.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841019109281 [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

[00841019109281]

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: 2016-07-20

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• 00841019109304: 8 1/2" Hardy Bayonet Forceps Insulated, with Stops, 0.25mm Tip
• 00841019109298: 8 1/2" Hardy Bayonet Forceps Insulated, with Stops, 0.5mm Tip, Angled Up
• 00841019109281: 8 1/2" Hardy Bayonet Forceps Insulated, with Stops, 0.5mm Tip
• 00841019109274: 8 1/2" Hardy Bayonet Forceps Insulated, 0.25mm Tip, Angled Down
• 00841019109267: 8 1/2" Hardy Bayonet Forceps Insulated, 0.25mm Tip, Angled Up
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• 00841019109243: 8 1/2" Hardy Bayonet Forceps Insulated, 0.25mm Tip