ION ESPS ARM FIXATION SYSTEM FM03-IF

GUDID 00860006375942

Infinitus Medical Technologies LLC

Operating table patient positioning set, single-use

• Primary Device ID: 00860006375942
• NIH Device Record Key: bc77f09e-eed9-41be-aa7f-d2b8b3c8e374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ION ESPS ARM FIXATION SYSTEM
• Version Model Number: FM03-IF
• Catalog Number: FM03-IF
• Company DUNS: 079575412
• Company Name: Infinitus Medical Technologies LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006375942 [Primary]

FDA Product Code

• CCX: Support, Patient Position

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: 2024-07-25
• Device Publish Date: 2024-07-17

On-Brand Devices [ION ESPS ARM FIXATION SYSTEM]

• 00860006375942: FM03-IF
• 00860006375935: FM02-IF
• 00860006375928: DP-01
• 00860006375911: IONESPS-2000