GENESIS BI-WING AAP IHS-1T2:12

GUDID 00195893257713

Infinitus Medical Technologies LLC

Operating table patient positioning set, single-use

• Primary Device ID: 00195893257713
• NIH Device Record Key: 8211118c-fe4f-4e31-83d9-f33ef6962da7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS BI-WING AAP
• Version Model Number: FPLS-2000
• Catalog Number: IHS-1T2:12
• 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	00195893257713 [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

Devices Manufactured by Infinitus Medical Technologies LLC

• 00195893257713 - GENESIS BI-WING AAP: 2024-07-25
• 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
• 00860003986882 - HADRON FPLS INFINITY, HDP: 2024-07-25
• 00860003986899 - HADRON FPLS INFINITY, XL: 2024-07-25
• 00860006375904 - KYBER SCC OFFSET UNIVERSAL RETRACTION POST SYSTEM: 2024-07-25
• 00860006375911 - ION ESPS ARM FIXATION SYSTEM: 2024-07-25