Titanex

GUDID 00841731105714

Screw, Titanex Lag 3.0x11mm_Ti Purple

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731105714
• NIH Device Record Key: 58ecb0ab-b323-44fb-ba73-e915a2dd10ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titanex
• Version Model Number: T30-11T-14
• 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	00841731105714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991197

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

Moist Heat or Steam Sterilization

[00841731105714]

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: 2016-08-03

On-Brand Devices [Titanex]

• 00841731106117: Screw, Titanex Lag 4.0x60mm_Ti Jade
• 00841731106100: Screw, Titanex Lag 4.0x58mm_Ti Jade
• 00841731106094: Screw, Titanex Lag 4.0x56mm_Ti Jade
• 00841731106087: Screw, Titanex Lag 4.0x54mm_Ti Jade
• 00841731106070: Screw, Titanex Lag 4.0x52mm_Ti Jade
• 00841731106063: Screw, Titanex Lag 4.0x50mm_Ti Jade
• 00841731106056: Screw, Titanex Lag 4.0x48mm_Ti Jade
• 00841731106049: Screw, Titanex Lag 4.0x46mm_Ti Jade
• 00841731106032: Screw, Titanex Lag 4.0x44mm_Ti Jade
• 00841731106025: Screw, Titanex Lag 4.0x42mm_Ti Jade
• 00841731106018: Screw, Titanex Lag 4.0x40mm_Ti Jade
• 00841731106001: Screw, Titanex Lag 4.0x38mm_Ti Jade
• 00841731105998: Screw, Titanex Lag 4.0x36mm_Ti Jade
• 00841731105981: Screw, Titanex Lag 4.0x34mm_Ti Jade
• 00841731105974: Screw, Titanex Lag 4.0x32mm_Ti Jade
• 00841731105967: Screw, Titanex Lag 4.0x30mm_Ti Jade
• 00841731105950: Screw, Titanex Lag 4.0x28mm_Ti Jade
• 00841731105943: Screw, Titanex Lag 4.0x26mm_Ti Jade
• 00841731105936: Screw, Titanex Lag 4.0x24mm_Ti Jade
• 00841731105929: Screw, Titanex Lag 4.0x22mm_Ti Jade
• 00841731105912: Screw, Titanex Lag 4.0x20mm_Ti Jade
• 00841731105905: Screw, Titanex Lag 3.0x40mm_Ti Purple
• 00841731105899: Screw, Titanex Lag 3.0x38mm_Ti Purple
• 00841731105882: Screw, Titanex Lag 3.0x36mm_Ti Purple
• 00841731105875: Screw, Titanex Lag 3.0x34mm_Ti Purple
• 00841731105868: Screw, Titanex Lag 3.0x32mm_Ti Purple
• 00841731105851: Screw, Titanex Lag 3.0x30mm_Ti Purple
• 00841731105844: Screw, Titanex Lag 3.0x28mm_Ti Purple
• 00841731105837: Screw, Titanex Lag 3.0x26mm_Ti Purple
• 00841731105820: Screw, Titanex Lag 3.0x24mm_Ti Purple
• 00841731105813: Screw, Titanex Lag 3.0x22mm_Ti Purple
• 00841731105806: Screw, Titanex Lag 3.0x20mm_Ti Purple
• 00841731105790: Screw, Titanex Lag 3.0x19mm_Ti Purple
• 00841731105783: Screw, Titanex Lag 3.0x18mm_Ti Purple
• 00841731105776: Screw, Titanex Lag 3.0x17mm_Ti Purple
• 00841731105769: Screw, Titanex Lag 3.0x16mm_Ti Purple
• 00841731105752: Screw, Titanex Lag 3.0x15mm_Ti Purple
• 00841731105745: Screw, Titanex Lag 3.0x14mm_Ti Purple
• 00841731105738: Screw, Titanex Lag 3.0x13mm_Ti Purple
• 00841731105721: Screw, Titanex Lag 3.0x12mm_Ti Purple
• 00841731105714: Screw, Titanex Lag 3.0x11mm_Ti Purple
• 00841731105707: Screw, Titanex Lag 3.0x10mm_Ti Purple
• 00841731105691: Screw, Titanex Lag 2.0x24mm_Ti L.Blue
• 00841731105684: Screw, Titanex Lag 2.0x22mm_Ti L.Blue
• 00841731105677: Screw, Titanex Lag 2.0x20mm_Ti L.Blue
• 00841731105660: Screw, Titanex Lag 2.0x19mm_Ti L.Blue
• 00841731105653: Screw, Titanex Lag 2.0x18mm_Ti L.Blue
• 00841731105646: Screw, Titanex Lag 2.0x17mm_Ti L.Blue
• 00841731105639: Screw, Titanex Lag 2.0x16mm_Ti L.Blue
• 00841731105622: Screw, Titanex Lag 2.0x15mm_Ti L.Blue