FlashPad

GUDID 00840682116732

GE MEDICAL SYSTEMS, INC.

Vascular dilator, single-use

• Primary Device ID: 00840682116732
• NIH Device Record Key: bbe03d5f-e328-4d84-b72a-9c6f6b7f4026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlashPad
• Version Model Number: 5340000-7
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682116732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102615

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [FlashPad]

• 00840682116732: 5340000-7
• 00840682116701: 5340000-8