Orthex Drill Solid

GUDID 00841731113283

Orthex, Drill 3.2x250mm Solid

VILEX IN TENNESSEE, INC.

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

• Primary Device ID: 00841731113283
• NIH Device Record Key: acea45d3-66dd-47ea-a984-0b1aee524d1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Drill Solid
• Version Model Number: Z402-250-32
• 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	00841731113283 [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

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

[00841731113283]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-07-02
• Device Publish Date: 2017-01-02

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