Vantage PSI 351-80-11

GUDID 00816847022606

Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides.

3D SYSTEMS, INC.

Osteotomy guide, reusable

• Primary Device ID: 00816847022606
• NIH Device Record Key: a3a0d6cf-8b43-414a-836c-60df1da45f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vantage PSI
• Version Model Number: Fluoroscopic Insert
• Catalog Number: 351-80-11
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com

Device Dimensions

• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847022606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193432

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

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

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-30
• Device Publish Date: 2020-11-13

On-Brand Devices [Vantage PSI]

• 00816847022590: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i
• 00816847022583: A physical guide that is composed of patient's bony anatomy and allows for precise location of p
• 00816847022606: Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cut
• 00816847022576: A physical guide that is composed of patient's bony anatomy and allows for precise location of p