VSP Cranial

GUDID 00816847021425

A physical template / guide that conforms to patients’ anatomy (Bony) to allow manipulation of free floating bony anatomy.

3D SYSTEMS, INC.

Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00816847021425
• NIH Device Record Key: 42b8a070-55b8-4e58-af16-cc0abeafd8db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSP Cranial
• Version Model Number: Cranial Positioning Guide
• 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: 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

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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00816847021425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151285

FDA Product Code

• PPT: Cranial Surgical Planning And Instrument Guides

Sterilization

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

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

[00816847021425]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-12

On-Brand Devices [VSP Cranial]

• 00816847021449: A physical template / guide that is positioned on patients’ anatomy (Bony), and allows for pre
• 00816847021432: A physical template / guide that is positioned on patients’ anatomy (Bony), and allows for pre
• 00816847021425: A physical template / guide that conforms to patients’ anatomy (Bony) to allow manipulation of