C-Flex

GUDID 10848340010719

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use

• Primary Device ID: 10848340010719
• NIH Device Record Key: 7ede0a69-a718-4247-85df-ee22c3b97349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Flex
• Version Model Number: A-70702
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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	00848340010712 [Primary]
GS1	10848340010719 [Package]; Contains: 00848340010712; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850959

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

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: 2026-03-20
• Device Publish Date: 2026-03-12

Devices Manufactured by ADVANCE MEDICAL DESIGNS, INC.

• 10848340010719 - C-Flex: 2026-03-20Disposable Equipment Cover
• 10848340010719 - C-Flex: 2026-03-20 Disposable Equipment Cover
• 10848340010481 - Mitaka Drape: 2024-04-25 Disposable Equipment Cover
• 10848340011464 - Mitaka Spy Elite: 2024-04-25 Disposable Equipment Cover
• 10848340015530 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340016834 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340016858 - Rolled Probe Cover: 2024-04-24 Disposable Equipment Cover
• 10848340015547 - Rolled Probe Cover: 2024-04-23 Disposable Equipment Cover
• 10848340012089 - Sterile Elastic Bands: 2024-04-22 Sterile Elastic Bands