TOTIM Patient Cushion Immobilization System

GUDID 08058045280460

ESSEBI MEDICAL SRL

Patient positioning foam mould kit

• Primary Device ID: 08058045280460
• NIH Device Record Key: 16f2a4b4-73c0-4267-945e-8482c6c2b1e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTIM Patient Cushion Immobilization System
• Version Model Number: TTM3010M NECK M
• Company DUNS: 440317440
• Company Name: ESSEBI MEDICAL SRL
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	08058045280170 [Primary]
GS1	08058045280460 [Unit of Use]

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: 2020-03-16
• Device Publish Date: 2020-03-06

On-Brand Devices [TOTIM Patient Cushion Immobilization System]

• 08058045280828: TTM3002L JOLLY L
• 08058045280811: TTM3009 TOTAL BODY
• 08058045280460: TTM3010M NECK M
• 08058045280415: TTM3005M CERVICAL M
• 08058045280057: TTM3002 JOLLY
• 08058045280026: TTM3001L BODY L