Reprocessed Somnoplasty Tissue Coagulating Electrode

GUDID B39022202210011

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: B39022202210011
• NIH Device Record Key: 4c4b0f62-ccaa-40a0-8888-c495b7630e06
• Commercial Distribution Discontinuation: 2025-04-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Somnoplasty Tissue Coagulating Electrode
• Version Model Number: 2220-2210-01
• 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	B39022202210011 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-09
• Device Publish Date: 2016-09-02

Devices Manufactured by SURETEK MEDICAL

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• B390KM35241 - Reprocessed Oscillating Sagittal Saw Blade, Thin, 25 x 5.5 x 0.38mm: 2024-09-16
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• B3903855450001 - Reprocessed 4.0mm Formula XL Tomcat Hip Cutter: 2024-07-08
• B390AR10001 - Reprocessed Suture Passer, Transosseous: 2024-05-27