AccuShape® Titanium Patient-Specific Cranial Implant MC-AST10

GUDID 00810007631035

Titanium Cranial Implant, Small

Medcad

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable

• Primary Device ID: 00810007631035
• NIH Device Record Key: dcd9e47d-a28a-4916-b528-dd3d2799ccd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuShape® Titanium Patient-Specific Cranial Implant
• Version Model Number: MC-AST10
• Catalog Number: MC-AST10
• Company DUNS: 144723868
• Company Name: Medcad
• 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: true
• 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: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com
• Phone: (214) 453-8864
• Email: support@medcad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007631035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220357

FDA Product Code

• GXN: Plate, Cranioplasty, Preformed, Non-Alterable

Sterilization

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

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

[00810007631035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [AccuShape® Titanium Patient-Specific Cranial Implant]

• 00810007631042: Titanium Cranial Implant, Medium
• 00810007631035: Titanium Cranial Implant, Small
• 00810007631028: Titanium Cranial Implant, Extra Large
• 00810007631011: Titanium Cranial Implant, Large
• 00810007631004: Titanium Cranial Implant, Medium