Reprocessed 1.7mm Cannulated Drill Bit

GUDID B390Z402100171

SURETEK MEDICAL

Fluted surgical drill bit, single-use

• Primary Device ID: B390Z402100171
• NIH Device Record Key: b16b9132-1982-4352-b6db-32ca71981768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reprocessed 1.7mm Cannulated Drill Bit
• Version Model Number: Z402-100-17
• 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	B390Z402100171 [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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Reprocessed 1.7mm Cannulated Drill Bit]

• B390Z402100171: Z402-100-17
• B390AR12017DC1: AR-1201-7DC