Reprocessed Reflex Ultra 55 PlasmaWand

GUDID B390EICA4855011

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: B390EICA4855011
• NIH Device Record Key: 2d593a4e-b39a-424f-8c84-2673234112c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Reflex Ultra 55 PlasmaWand
• Version Model Number: EICA4855-01
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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
HIBCC	B390EICA4855011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052692

FDA Product Code

• NUJ: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-20
• Device Publish Date: 2021-08-12

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