Orthex Tool

GUDID 00841731118943

X-Ray Ball Bridge, SB 75mm

VILEX IN TENNESSEE, INC.

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

• Primary Device ID: 00841731118943
• NIH Device Record Key: e82f528b-37ce-4318-ba9a-3495963a40b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthex Tool
• Version Model Number: CB-075B
• 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: false
• 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	00841731118943 [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

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

[00841731118943]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-07-02
• Device Publish Date: 2019-07-26

On-Brand Devices [Orthex Tool]

• 00841731117748: Orthex Sleeve wire SB 5x4.5x100mm
• 00841731117731: Orthex Sleeve wire SB 4.5x1.5x110mm
• 00841731117717: Half Pin Removal Tool (LB)
• 00841731117588: Half Pin Removal Tool (SB)
• 00841731117267: Orthex Wire Sleeve 4.5x1.8x110mm
• 00841731123268: Pin Shears, Double Action 22" (4.5-6.0)
• 00841731123343: X-Ray Ball Bridge, 280mm
• 00841731123336: X-Ray Ball Bridge, 255mm
• 00841731123350: X-Ray Ball Bridge, SB 60mm
• 00841731122117: 4.8 drill sleeve, Short
• 00841731122100: 4.8 drill sleeve, Long
• 00841731121530: X-Ray Ball Bridge, 230mm
• 00841731121523: X-Ray Ball Bridge, 205mm
• 00841731121516: X-Ray Ball Bridge, 180mm
• 00841731121509: X-Ray Ball Bridge, 155mm
• 00841731121493: X-Ray Ball Bridge, 130mm
• 00841731121486: X-Ray Ball Bridge, 105mm
• 00841731118974: X-Ray Ball Bridge, SB 130mm
• 00841731118967: X-Ray Ball Bridge, SB 110mm
• 00841731118950: X-Ray Ball Bridge, SB 95mm
• 00841731118943: X-Ray Ball Bridge, SB 75mm
• 00841731118882: Orthex, Handle, AO Pull Adpt