Reprocessed 3.0mm VAPR Premiere 50 Electrode

GUDID B3902275041

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

• Primary Device ID: B3902275041
• NIH Device Record Key: eef996af-9406-426f-accd-3816b6f8fff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 3.0mm VAPR Premiere 50 Electrode
• Version Model Number: 227504
• 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	B3902275041 [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: 2018-12-10
• Device Publish Date: 2018-11-08

Devices Manufactured by SURETEK MEDICAL

• B3901431401 - Reprocessed Mako Bone Pins 3.2mm x 140mm: 2024-10-02
• B3901441401 - Reprocessed Mako Bone Pins 4mm x 140mm: 2024-10-02
• B390AR606845LX1 - Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Left, w/out Nitinol Wire: 2024-09-16
• B390AR606845RX1 - Reprocessed QuickPass SutureLasso, 45 Deg, Curve, Right, w/out Nitinol Wire: 2024-09-16
• B390KM35241 - Reprocessed Oscillating Sagittal Saw Blade, Thin, 25 x 5.5 x 0.38mm: 2024-09-16
• B39060143261 - Reprocessed 1.4mm Twist Drill, WL 27mm, AO-Shaft: 2024-07-31
• B3903855450001 - Reprocessed 4.0mm Formula XL Tomcat Hip Cutter: 2024-07-08
• B390AR10001 - Reprocessed Suture Passer, Transosseous: 2024-05-27