Reprocessed Shaver Blade Straight 3.0mm Double Serrated

GUDID B39016005381

SURETEK MEDICAL

ENT suction dissector

• Primary Device ID: B39016005381
• NIH Device Record Key: 463aa0c2-77eb-4ea8-956c-182bdac842b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Shaver Blade Straight 3.0mm Double Serrated
• Version Model Number: 1600538
• 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	B39016005381 [Primary]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

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: 2025-06-09
• Device Publish Date: 2025-05-30

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• B390KM35251 - Reprocessed Small Bone Osc Sagittal Blade, Thin, 31 x 9 x 0.38mm: 2025-09-15
• B390311340681 - Reprocessed 4mm Round Fine Diamond Bur Long: 2025-07-31
• B390030001131 - Reprocessed 2.3mm Lindemann Reamer: 2025-07-28
• B39016005401 - Reprocessed Shaver Blade Straight 4.0mm Double Serrated: 2025-06-30