Orthex Drill Solid Z402P-160-35S

GUDID 00841731121912

Orthex Drill 3.5x160mm, Solid, Centering Tip

VILEX IN TENNESSEE, INC.

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

• Primary Device ID: 00841731121912
• NIH Device Record Key: 16cbbf48-6f83-4c3b-b17d-af735fde2384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Drill Solid
• Version Model Number: Z402P-160-35S
• Catalog Number: Z402P-160-35S
• 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	00841731121912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151881

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

Moist Heat or Steam Sterilization

[00841731121912]

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 Solid]

• 00841731121936: Orthex Drill 3.5x250mm, Solid, Centering Tip
• 00841731121929: Orthex Drill 2.7x250mm, Solid, Centering Tip
• 00841731121912: Orthex Drill 3.5x160mm, Solid, Centering Tip
• 00841731121899: Orthex Drill 2.7x160mm, Solid, Centering Tip
• 00841731121875: Orthex Drill 2.0x160mm, Solid, Centering Tip
• 00841731121189: Orthex Drill 4.8x250mm, Solid, Centering Tip
• 00841731113375: Orthex Drill 3.5x275mm Solid
• 00841731113368: Orthex Drill 2.7x275mm Solid
• 00841731113320: Orthex Drill 4.5x275mm Solid
• 00841731113313: Orthex Drill 3.2x275mm Solid
• 00841731113306: Orthex Drill 2.0x275mm Solid
• 00841731113290: Orthex, Drill 4.5x250mm Solid
• 00841731113283: Orthex, Drill 3.2x250mm Solid
• 00841731113221: Orthex, Drill 4.5x185mm Solid
• 00841731113214: Orthex, Drill 3.2x185mm Solid
• 00841731113207: Orthex, Drill 2.0x185mm Solid