Reprocessed 2.3mm Lindemann Reamer

GUDID B390030001131

SURETEK MEDICAL

Orthopaedic bur, reusable

• Primary Device ID: B390030001131
• NIH Device Record Key: f5f3d8d6-5613-4bf9-98ae-c2b826b7996c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 2.3mm Lindemann Reamer
• Version Model Number: 03.000.113
• 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	B390030001131 [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: 2025-07-28
• Device Publish Date: 2025-07-18

Devices Manufactured by SURETEK MEDICAL

• B390311340681 - Reprocessed 4mm Round Fine Diamond Bur Long: 2025-07-31
• B390030001131 - Reprocessed 2.3mm Lindemann Reamer: 2025-07-28
• B390030001131 - Reprocessed 2.3mm Lindemann Reamer: 2025-07-28
• B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated: 2025-06-30
• B39062901120401 - Reprocessed 4mm Straight Shaver Blade: 2025-06-13
• B39062902080251 - Reprocessed 2.5mm Straight Shaver Blade: 2025-06-13
• B39072053121 - Reprocessed 3.5mm Incisor Blade: 2025-06-13
• B39016005381 - Reprocessed Shaver Blade Straight 3.0mm Double Serrated: 2025-06-09
• B39016010701 - Reprocessed Shaver Blade Straight 2.1mm Double Serrated: 2025-06-09