Sonigel Ultrasound Gel Couplants 1853

GUDID 10816864020064

Sonigel 1853 (4 x 5 liters)

METTLER ELECTRONICS CORP.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 10816864020064
• NIH Device Record Key: 33a825dd-f7be-42fb-b799-e2d7735cb84c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonigel Ultrasound Gel Couplants
• Version Model Number: 1853
• Catalog Number: 1853
• Company DUNS: 008513913
• Company Name: METTLER ELECTRONICS CORP.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816864020064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012522

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2017-01-26

On-Brand Devices [Sonigel Ultrasound Gel Couplants]

• 00816864020067: Sonigel 1852 (1 x 5 liters)
• 10816864020040: Sonigel (250ml bottle)
• 10816864020026: Sonigel (8.5 oz.tube)
• 10816864020064: Sonigel 1853 (4 x 5 liters)