ECO SUPERGEL CLEAR

GUDID 08057733230176

ULTRASOUND TRANSMISSIONE GEL CLEAR 260 GR.

CERACARTA SPA

Topical coupling gel, non-sterile

• Primary Device ID: 08057733230176
• NIH Device Record Key: 7f6b80ab-9621-487c-b265-63ee9a583c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO SUPERGEL CLEAR
• Version Model Number: ULTRASOUND GEL CLEAR 260 G
• 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: true
• 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	08057733230176 [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 CLEAR]

• 08057733230176: ULTRASOUND TRANSMISSIONE GEL CLEAR 260 GR.
• 08057733230145: ULTRASOUND TRASMISSION GEL CLEAR 5 LT.