Reprocessed Oscillating Saw Blade, 34.5 x 16.5mm

GUDID B390229635041

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered

• Primary Device ID: B390229635041
• NIH Device Record Key: a15fa2d7-d719-4c80-b75c-5e7c46050aac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Oscillating Saw Blade, 34.5 x 16.5mm
• Version Model Number: 2296-3-504
• 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	B390229635041 [Primary]

FDA Product Code

• GFA: Blade, Saw, General & Plastic Surgery, Surgical

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: 2021-05-04
• Device Publish Date: 2021-04-26

Devices Manufactured by SURETEK MEDICAL

• B3901161701 - Reprocessed Mako Blade Standard, 2mm: 2025-09-26
• B3901161711 - Reprocessed Mako Blade Narrow, 2mm: 2025-09-26
• B39021081821 - Reprocessed Sagittal Saw Blade, 18.6 x 1.24 x 84.4mm: 2025-09-15
• B3903105201 - Reprocessed 1.8mm Drill Bit, Quick Coupling, 125mm: 2025-09-15
• 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