Snap Kover

GUDID 10848340018975

Non-Sterile

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile Medical equipment handle cover, single-use, sterile

• Primary Device ID: 10848340018975
• NIH Device Record Key: c25343ac-ce61-46bb-ab26-39740064f51e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Snap Kover
• Version Model Number: 02-4036TL
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340018978 [Primary]
GS1	10848340018975 [Package]; Contains: 00848340018978; Package: [100 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: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [Snap Kover]

• 10848340015424: Disposable Equipment Cover
• 10848340009638: Disposable Equipment Cover
• 10848340018975: Non-Sterile
• 10848340018753: Non-Sterile
• 10848340019781: Disposable Equipment Cover
• 10848340016865: Snap Kover
• 10848340017022: Snap Kover
• 10848340009621: Snap Kover
• 10848340002318: w/Additional Band