PC15 PLASMAKNIFE DISPOSABLE TIP

GUDID 00821925026735

Gyrus Acmi, Inc.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00821925026735
• NIH Device Record Key: 0ce42d76-98de-4275-afcb-f7c1a8dedf6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PC15 PLASMAKNIFE DISPOSABLE TIP
• Version Model Number: 70353115
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925026735 [Package]; Contains: 00821925040526; Package: [4 Units]; In Commercial Distribution
GS1	00821925040526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041285

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-11

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