Reprocessed 2.0mm Wire Pass Drill Bit, 50.8mm

GUDID B390530010711

SURETEK MEDICAL

Fluted surgical drill bit, single-use

• Primary Device ID: B390530010711
• NIH Device Record Key: 8fe1cf73-3ff6-4aaa-bf17-0491594797ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 2.0mm Wire Pass Drill Bit, 50.8mm
• Version Model Number: 5300-10-71
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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
HIBCC	B390530010711 [Primary]

FDA Product Code

• HTW: Bit, Drill

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: 2022-02-17
• Device Publish Date: 2022-02-09

Devices Manufactured by SURETEK MEDICAL

• B3902141071 - Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm: 2024-12-23
• B3902141081 - Reprocessed Threaded Clear Cannula with Obturator, 5.5mm x 75mm: 2024-12-23
• B390AR406845L1 - Reprocessed SutureLasso, 45 Deg, Curve Left: 2024-12-23
• B390S8966561 - Reprocessed Sagittal Saw Blade, 90 x 19 x 1.27mm: 2024-12-23
• B390AR8750131 - Reprocessed 3.7mm Cannulated Drill Bit: 2024-11-27
• B390722901351 - Reprocessed Werewolf Irrigation Tube Set: 2024-11-18
• B390AR65301 - Reprocessed Twist-in Cannula w/Obturator, 8.25mm x 7cm: 2024-10-28
• B39057S000221 - Reprocessed Mica Drill Bit, 2.2mm: 2024-10-24