Vilex Drill

GUDID 00841731119636

Drill, 3.5mm Solid QC, 41mm flute (AVID)

VILEX IN TENNESSEE, INC.

Fluted surgical drill bit, single-use, non-sterile

• Primary Device ID: 00841731119636
• NIH Device Record Key: 0f2c7b52-2bf7-4501-8fd1-90f0fa66cc6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Drill
• Version Model Number: DA3541
• Company DUNS: 152008371
• Company Name: VILEX IN TENNESSEE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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
GS1	00841731119636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041287

FDA Product Code

• HTW: Bit, Drill

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

[00841731119636]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-10-26

On-Brand Devices [Vilex Drill ]

• 00841731119650: Drill, 3.5mm Solid QC, 195/50mm flute (AVID)
• 00841731119643: Drill, 2.7mm Solid QC, 29mm flute (AVID)
• 00841731119636: Drill, 3.5mm Solid QC, 41mm flute (AVID)