Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm

GUDID B390KM31011

SURETEK MEDICAL

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• Primary Device ID: B390KM31011
• NIH Device Record Key: 4c064a21-1a9d-4fb4-96c9-1bad1f5feeaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed Sagittal Saw Blade, Small Bone, 25.4 x 9.5 x 0.63mm
• Version Model Number: KM-3101
• 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	B390KM31011 [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

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