Vilex Fibula Drill ZF-DRLL-20

GUDID 00841731121998

Drill, Fibula 2.0x230mm

VILEX IN TENNESSEE, INC.

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

• Primary Device ID: 00841731121998
• NIH Device Record Key: cc9e1e7f-ceab-4ebc-8f07-9f3ccb509475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Fibula Drill
• Version Model Number: ZF-DRLL-20
• Catalog Number: ZF-DRLL-20
• 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	00841731121998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151456

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

[00841731121998]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-08-14

On-Brand Devices [Vilex Fibula Drill]

• 00841731122001: Drill, Fibula 2.5x245mm
• 00841731121998: Drill, Fibula 2.0x230mm