ECO SUPERGEL

GUDID 08057733230107

ULTRASOUND TRANSMISSION GEL 5 LT.

CERACARTA SPA

Topical coupling gel, non-sterile

• Primary Device ID: 08057733230107
• NIH Device Record Key: b94d5dec-0740-4360-a749-9dd0f8f57eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO SUPERGEL
• Version Model Number: ULTRASOUND GEL
• Company DUNS: 429173701
• Company Name: CERACARTA SPA
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08057733230107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101429

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-12-18

On-Brand Devices [ECO SUPERGEL]

• 08057733230107: ULTRASOUND TRANSMISSION GEL 5 LT.
• 08057733230084: ULTRASOUND TRANSMISSION GEL 260 GR.