Reprocessed 3.2mm, Opus Magnum Spade Drill

GUDID B390OM90101

SURETEK MEDICAL

Fluted surgical drill bit, single-use

• Primary Device ID: B390OM90101
• NIH Device Record Key: e039d8d6-2445-4a8d-88f0-8e8af2ba6962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 3.2mm, Opus Magnum Spade Drill
• Version Model Number: OM-9010
• 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	B390OM90101 [Primary]

FDA Product Code

• HTW: Bit, Drill

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: 2022-05-03
• Device Publish Date: 2022-04-25

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