LUNA SUPINE PAD SYSTEM

GUDID 00860006375959

Infinitus Medical Technologies LLC

Operating table patient positioning set, single-use

• Primary Device ID: 00860006375959
• NIH Device Record Key: f3a59321-4d3f-4e20-8c74-0974ccdc78bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUNA SUPINE PAD SYSTEM
• Version Model Number: SP-3500
• Company DUNS: 079575412
• Company Name: Infinitus Medical Technologies LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• 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	00860006375959 [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: 2025-08-04
• Device Publish Date: 2025-07-25

Devices Manufactured by Infinitus Medical Technologies LLC

• 00195893164608 - AXILLARY POSITIONING ROLL: 2025-08-04
• 00195893397556 - AZUL, ITPW: 2025-08-04
• 00860006375959 - LUNA SUPINE PAD SYSTEM: 2025-08-04
• 00860006375959 - LUNA SUPINE PAD SYSTEM: 2025-08-04
• 00860006375966 - KIT, CHEST PAD AND STRAP: 2025-08-04
• 00195893257713 - GENESIS BI-WING AAP: 2024-07-25
• 00195893509492 - VISIWRAP SURGICAL FACE PROTECTOR: 2024-07-25
• 00860003986868 - GENESIS BI-WING AAP, XL: 2024-07-25
• 00860003986875 - HADRON FPLS INFINITY: 2024-07-25