PKS Plasma-Cut 5 Fr (1.67) Electrode/33cm

GUDID 00821925010499

Gyrus Acmi, Inc.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00821925010499
• NIH Device Record Key: 8a3e612d-1e86-450d-a49a-85536d4d5f66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS Plasma-Cut 5 Fr (1.67) Electrode/33cm
• Version Model Number: 714510
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925010499 [Package]; Contains: 00821925035966; Package: [5 Units]; In Commercial Distribution
GS1	00821925035966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990628

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-13

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