TITAN 3-D Wedge System P03-940-9002

GUDID 00889795020055

TITAN, Cotton Resection Guide - Even Sizes

PARAGON 28, INC.

Osteotomy guide Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable

• Primary Device ID: 00889795020055
• NIH Device Record Key: 8ce29c3e-6776-4794-9494-c7cf3a786cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITAN 3-D Wedge System
• Version Model Number: P03-940-9002
• Catalog Number: P03-940-9002
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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	00889795020055 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

[00889795020055]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-24
• Device Publish Date: 2020-01-16

On-Brand Devices [TITAN 3-D Wedge System]

• 00889795020062: TITAN, Cotton Resection Guide - Odd Sizes
• 00889795020055: TITAN, Cotton Resection Guide - Even Sizes
• 00889795020048: TITAN, Evans Resection Guide
• 00889795018236: TITAN 3-D Wedge, Cotton, 8mm, Sterile
• 00889795018229: TITAN 3-D Wedge, Cotton, 7mm, Sterile
• 00889795018212: TITAN 3-D Wedge, Cotton, 6mm, Sterile
• 00889795018205: TITAN 3-D Wedge, Cotton, 5mm, Sterile
• 00889795018199: TITAN 3-D Wedge, Evans, Large, 12mm, Sterile
• 00889795018182: TITAN 3-D Wedge, Evans, Large, 10mm, Sterile
• 00889795018175: TITAN 3-D Wedge, Evans, Large, 8mm, Sterile
• 00889795018168: TITAN 3-D Wedge, Evans, Large, 6mm, Sterile
• 00889795018151: TITAN 3-D Wedge, Evans, Small, 12mm, Sterile
• 00889795018144: TITAN 3-D Wedge, Evans, Small, 10mm, Sterile
• 00889795018137: TITAN 3-D Wedge, Evans, Small, 8mm, Sterile
• 00889795018120: TITAN 3-D Wedge, Evans, Small, 6mm, Sterile
• 00889795050755: TRIAL HANDLE, EVANS, 10mm
• 00889795050748: TRIAL HANDLE, COTTON, 6mm
• 00889795020109: TITAN, Cotton Precision Screw Guide, Left
• 00889795020093: TITAN, Cotton Precision Screw Guide, Right
• 00889795020086: TITAN, Evans Precision Screw Guide, Left
• 00889795020079: TITAN, Evans Precision Screw Guide, Right
• 00889795020031: TITAN, Cotton Wedge Inserter
• 00889795020024: TITAN, Evans Wedge Inserter
• 00889795020017: Resection Guide Attachment Hex Handle
• 00889795020000: TITAN Caddy Lid
• 00889795019981: TITAN Instrument Caddy Base
• 00889795019998: TITAN Trial Caddy Base