AccuShape® ACS-001

GUDID 00810007630007

PEEK Cranial Implant, Small

Medcad

Cranioplasty plate, non-alterable

• Primary Device ID: 00810007630007
• NIH Device Record Key: e1d53b60-85ed-4a56-9eda-2967faf5289e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuShape®
• Version Model Number: ACS-001
• Catalog Number: ACS-001
• Company DUNS: 144723868
• Company Name: Medcad
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810007630007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110684

FDA Product Code

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

Sterilization

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

[00810007630007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [AccuShape®]

• 00810007630137: PEEK Cranial Implant, XXL
• 00810007630120: PEEK Cranial Implant, Extra Large
• 00810007630113: PEEK Cranial Implant, Large
• 00810007630106: PEEK Cranial Implant, Medium
• 00810007630090: PEEK Cranial Implant, Small
• 00810007630083: PEEK Cranial Implant, Extra Small
• 00810007630076: PEEK Cranial Implant, Extra Large
• 00810007630069: PEEK Cranial Implant, Large
• 00810007630052: PEEK Cranial Implant, Medium
• 00810007630045: PEEK Cranial Implant, Small
• 00810007630038: PEEK Cranial Implant, Extra Large
• 00810007630021: PEEK Cranial Implant, Large
• 00810007630014: PEEK Cranial Implant, Medium
• 00810007630007: PEEK Cranial Implant, Small
• 00810007630175: PEEK Cranial Implant, Large
• 00810007630168: PEEK Cranial Implant, Small
• 00810007630632: PEEK Cranial Implant, Extra Large
• 00810007630625: PEEK Cranial Implant, Large
• 00810007630618: PEEK Cranial Implant, Medium
• 00810007630182: PEEK Cranial Implant, Small