Vilex Implant Accessory

GUDID 00841731114853

Washer, 7.2mm Ti Screw

VILEX IN TENNESSEE, INC.

Orthopaedic bone washer, non-sterile

• Primary Device ID: 00841731114853
• NIH Device Record Key: 1120bb19-662c-4e68-83ec-f4a1be1906df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Implant Accessory
• Version Model Number: 635-72T
• 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	00841731114853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991151

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

Moist Heat or Steam Sterilization

[00841731114853]

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: 2017-02-02

On-Brand Devices [Vilex Implant Accessory]

• 00841731114884: Washer, 4.0mm Ti - T40 Screw
• 00841731114877: Washer, 3.0mm Ti - T30 Screw
• 00841731114860: Washer, 2.0mm Ti - T20 Screw
• 00841731114853: Washer, 7.2mm Ti Screw
• 00841731114846: Washer, 6.5mm Ti Screws .468x.275x.040
• 00841731114839: Washer, 6.5mm SS Screw 468x.275x.040
• 00841731114822: Washer, 4.5mm Ti Screw 328x.218x.040
• 00841731114815: Washer, 4.5mm SS Screw 328x.218x.040
• 00841731114808: Washer, 4.0mm Ti Screw 312x.175x.040
• 00841731114792: Washer, 4.0mm SS Screw 312x.175x.040