Vilex Dual Thread Screw

GUDID 00841731100405

Screw, Headless 2.5x18mm_SS

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731100405
• NIH Device Record Key: 36c49421-8403-45ed-992b-71bfa03d16fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Dual Thread Screw
• Version Model Number: F25-18S-09
• 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	00841731100405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014154

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

[00841731100405]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-22

On-Brand Devices [Vilex Dual Thread Screw]

• 00841731114723: Screw, Headless 2.5x36mm_Ti Green
• 00841731114556: Screw, Headless 2.5x30mm_Ti Green
• 00841731114549: Screw, Headless 2.5x28mm_Ti Green
• 00841731114532: Screw, Headless 2.5x26mm_Ti Green
• 00841731113092: Screw, Headless 5.0x095mm XST_Ti Blue
• 00841731113085: Screw, Headless 5.0x090mm XST_Ti Blue
• 00841731113078: Screw, Headless 5.0x085mm XST_Ti Blue
• 00841731113061: Screw, Headless 5.0x080mm XST_Ti Blue
• 00841731113054: Screw, Headless 5.0x075mm XST_Ti Blue
• 00841731112941: Screw, Headless 5.0x070mm XST_Ti Blue
• 00841731112934: Screw, Headless 5.0x065mm XST_Ti Blue
• 00841731112927: Screw, Headless 5.0x060mm XST_Ti Blue
• 00841731112910: Screw, Headless 5.0x055mm XST_Ti Blue
• 00841731112903: Screw, Headless 5.0x050mm XST_Ti Blue
• 00841731112897: Screw, Headless 5.0x045mm XST_Ti Blue
• 00841731112880: Screw, Headless 5.0x040mm XST_TiBlue
• 00841731112873: Screw, Headless 5.0x035mm XST_TiBlue
• 00841731112866: Screw, Headless 5.0x030mm XST_Ti Blue
• 00841731112859: Screw, Headless 5.0x110mm XST_Ti Blue
• 00841731112842: Screw, Headless 5.0x105mm XST_Ti Blue
• 00841731106902: Screw, Headless 2.0x29mm_Ti Green
• 00841731106896: Screw, Headless 5.0x100mm XST_Ti Blue
• 00841731102232: Screw Headless 9.0x090mm_Ti Green
• 00841731102225: Screw Headless 9.0x080mm_Ti Green
• 00841731102218: Screw Headless 9.0x070mm_Ti Green
• 00841731102201: Screw Headless 9.0x060mm_Ti Green
• 00841731102195: Screw Headless 9.0x250mm_Ti Green
• 00841731102188: Screw Headless 9.0x200mm_Ti Green
• 00841731102171: Screw Headless 9.0x160mm_Ti Green
• 00841731102164: Screw Headless 9.0x150mm_Ti Green
• 00841731102157: Screw Headless 9.0x140mm_Ti Green
• 00841731102140: Screw Headless 9.0x130mm_Ti Green
• 00841731102133: Screw Headless 9.0x120mm_Ti Green
• 00841731102126: Screw Headless 9.0x110mm_Ti Green
• 00841731102119: Screw Headless 9.0x100mm_Ti Green
• 00841731102102: Screw, Headless 8.0x095mm ST_Ti Green
• 00841731102096: Screw, Headless 8.0x095mm_Ti Green
• 00841731102089: Screw, Headless 8.0x090mm ST_Ti Green
• 00841731102072: Screw, Headless 8.0x090mm_Ti Green
• 00841731102065: Screw, Headless 8.0x085mm ST_Ti Green
• 00841731102058: Screw, Headless 8.0x085mm_Ti Green
• 00841731102041: Screw, Headless 8.0x080mm ST_Ti Green
• 00841731102034: Screw, Headless 8.0x080mm_Ti Green
• 00841731102027: Screw, Headless 8.0x075mm ST_Ti Green
• 00841731102010: Screw, Headless 8.0x075mm_Ti Green
• 00841731102003: Screw, Headless 8.0x070mm ST_Ti Green
• 00841731101990: Screw, Headless 8.0x070mm_Ti Green
• 00841731101983: Screw, Headless 8.0x065mm ST_Ti Green
• 00841731101976: Screw, Headless 8.0x060mm ST_Ti Green
• 00841731101969: Screw, Headless 8.0x055mm ST_Ti Green