Preserve Bone Wedge Trials PET-3DP-0004

GUDID 00889795146595

3D Printed Evans Trial, 4mm

Paragon 28, Inc.

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00889795146595
• NIH Device Record Key: 3074ce52-9bac-42b3-b084-aa4423aeaa03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Preserve Bone Wedge Trials
• Version Model Number: PET-3DP-0004
• Catalog Number: PET-3DP-0004
• Company DUNS: 042961576
• Company Name: Paragon 28, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• 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	00889795146595 [Primary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Preserve Bone Wedge Trials]

• 00889795146601: 3D Printed Lapidus Trial, 4mm, 0Deg
• 00889795146595: 3D Printed Evans Trial, 4mm
• 00889795146588: 3D Printed Cotton Trial, 10mm
• 00889795146571: 3D Printed Cotton Trial, 9mm