Cannulated 1st MPJ Hemi Implant

GUDID 00841731106216

Cannulated Hemi Implant #3 19x17 Cocr HA Coated

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731106216
• NIH Device Record Key: 84a6447e-bd12-47cf-ad8a-cc10f45628ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated 1st MPJ Hemi Implant
• Version Model Number: CHI-3CH
• 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	00841731106216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102401

FDA Product Code

• KWD: Prosthesis, Toe, Hemi-, Phalangeal

Sterilization

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

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

Moist Heat or Steam Sterilization

[00841731106216]

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: 2016-08-04

On-Brand Devices [Cannulated 1st MPJ Hemi Implant]

• 00841731106315: Cannulated Hemi Implant #5 24x21 Ti HA Coated Bronze
• 00841731106308: Cannulated Hemi Implant #5 24x21 Ti Bronze
• 00841731106292: Cannulated Hemi Implant #5 24x21 CoCr HA Coated
• 00841731106285: Cannulated Hemi Implant #5 24x21 CoCr
• 00841731106278: Cannulated Hemi Implant #4 22x19 Ti HA Coated Green
• 00841731106261: Cannulated Hemi Implant #4 22x19 Ti Green
• 00841731106254: Cannulated Hemi Implant #4 22x19 CoCr HA Coated
• 00841731106247: Cannulated Hemi Implant #4 22x19 CoCr
• 00841731106230: Cannulated Hemi Implant #3 19x17 Ti HA Coated Magenta
• 00841731106223: Cannulated Hemi Implant #3 19x17 Ti Magenta
• 00841731106216: Cannulated Hemi Implant #3 19x17 Cocr HA Coated
• 00841731106209: Cannulated Hemi Implant #3 19x17 CoCr
• 00841731106193: Cannulated Hemi Implant #2 17x15 Ti HA Coated Gold
• 00841731106186: Cannulated Hemi Implant #2 17x15 Ti, Gold
• 00841731106179: Cannulated Hemi Implant #2 17x15 CoCr HA Coated
• 00841731106162: Cannulated Hemi Implant #2 17x15 CoCr
• 00841731106155: Cannulated Hemi Implant #1 15x13 Ti HA Coated Blue
• 00841731106148: Cannulated Hemi Implant #1 15x13 Ti, Blue
• 00841731106131: Cannulated Hemi Implant #1 15x13 Cocr HA Coated
• 00841731106124: Cannulated Hemi Implant #1 15x13 CoCr