Orthex Drill Cannulated Z402P-160-27C

GUDID 00841731121882

Orthex Drill 2.7x160mm, Cannulated

VILEX IN TENNESSEE, INC.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00841731121882
• NIH Device Record Key: cfb08670-5bc9-4629-b191-86b28866dda1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Drill Cannulated
• Version Model Number: Z402P-160-27C
• Catalog Number: Z402P-160-27C
• 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	00841731121882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

[00841731121882]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-07-02
• Device Publish Date: 2018-03-09

On-Brand Devices [Orthex Drill Cannulated]

• 00841731121905: Orthex Drill 3.5x160mm, Cannulated
• 00841731121882: Orthex Drill 2.7x160mm, Cannulated
• 00841731113351: Orthex Drill 3.5x200mm Cannulated
• 00841731113344: Orthex Drill 2.7x200mm Cannulated
• 00841731113276: Orthex Drill 5.0x200mm Cannulated
• 00841731113269: Orthex Drill 4.5x200mm Cannulated
• 00841731113252: Orthex Drill 4.0x200mm Cannulated
• 00841731113245: Orthex Drill 3.5x200mm Cannulated
• 00841731113238: Orthex Drill 3.2x200mm Cannulated