Reprocessed TAC-C II Probe, Monopolar

GUDID B39072096281

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed

• Primary Device ID: B39072096281
• NIH Device Record Key: 58f9497a-d747-4963-ab49-a0906ed8318b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed TAC-C II Probe, Monopolar
• Version Model Number: 7209628
• 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	B39072096281 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by SURETEK MEDICAL

• 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
• B390C9944A1 - Reprocessed 2.9mm Full Radius Resector: 2024-05-20
• B39044471 - Reprocessed ECTRA II, Probe Knife: 2024-02-29