Reprocessed Medium Narrow Blade, 18 x 5.5mm

GUDID B390KM34121

SURETEK MEDICAL

Surgical power tool system handpiece, sawing, line-powered

• Primary Device ID: B390KM34121
• NIH Device Record Key: da1c412b-dcff-47cf-a831-0ac39484c599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Medium Narrow Blade, 18 x 5.5mm
• Version Model Number: KM3-412
• 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	B390KM34121 [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: 2021-05-28
• Device Publish Date: 2021-05-20

On-Brand Devices [Reprocessed Medium Narrow Blade, 18 x 5.5mm]

• B390229634121: 2296-3-412
• B390KM34121: KM3-412