Reprocessed 4.0mm Round Resurfacing Tool

GUDID B39019000100401

SURETEK MEDICAL

Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use Orthopaedic bur, single-use

• Primary Device ID: B39019000100401
• NIH Device Record Key: 41901cad-c97c-4d24-8260-aabdaff7db6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 4.0mm Round Resurfacing Tool
• Version Model Number: 1900-010-040
• 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	B39019000100401 [Primary]

FDA Product Code

• HTT: Burr, Orthopedic

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: 2021-11-18
• Device Publish Date: 2021-11-10

Devices Manufactured by SURETEK MEDICAL

• B39044471 - Reprocessed ECTRA II, Probe Knife: 2024-02-29
• B390AR659208401 - Reprocessed PassPort Button Cannula, 8mm x 4cm: 2024-02-29
• B390138505101 - Reprocessed MicroNeedle 3cm: 2024-02-28
• B3905100371131 - Reprocessed Small Tear Cross Cut Rasp, 11mm x 5mm: 2024-02-20
• B3905100371141 - Reprocessed Large Tear Cross Cut Rasp, 14.0mm x 7.0mm: 2024-02-20
• B390810101 - Reprocessed Carpal Tunnel Release Blade: 2024-02-02
• B3901912050T1 - Reprocessed 4mm EndoScrub Sheath, 0 deg, w/Tubing: 2024-01-04
• B390E16511 - Reprocessed Straight Micro-Needle Electrode, 3cm: 2023-12-25