CRANIAL 4PI CT TABLE OVERLAY

GUDID 04056481141363

Brainlab AG

Indexed-immobilization patient positioning system

• Primary Device ID: 04056481141363
• NIH Device Record Key: 577d8616-7549-4deb-85ba-554a0e4bcc08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRANIAL 4PI CT TABLE OVERLAY
• Version Model Number: 43430
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481141363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202050

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

Devices Manufactured by Brainlab AG

• 04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.): 2024-07-26
• 04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.): 2024-07-26
• 04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.): 2024-07-26
• 04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.): 2024-07-26
• 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.): 2024-07-26
• 04056481144968 - CRANIAL 4PI OPEN FACE MASK (1 PC.): 2024-07-26
• 04056481144975 - CRANIAL 4PI EXTENDED MASK (5 PCS.): 2024-07-26
• 04056481144982 - CRANIAL 4PI EXTENDED MASK (1 PC.): 2024-07-26