TrueForm

GUDID 00815212021022

Izi Medical Products, LLC

Vacuum-mould patient positioning system Vacuum-mould patient positioning system

• Primary Device ID: 00815212021022
• NIH Device Record Key: f30445de-e86e-49fc-85f0-d55c5233ee54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueForm
• Version Model Number: TF6001
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212021022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132124

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-16

On-Brand Devices [TrueForm]

• 00815212021688: TF6006
• 00815212021060: TF6005
• 00815212021053: TF6004
• 00815212021046: TF6003
• 00815212021039: TF6002
• 00815212021022: TF6001