Sonigel Ultrasound Gel Couplants 1853

GUDID 10816864020064

Sonigel 1853 (4 x 5 liters)

METTLER ELECTRONICS CORP.

Transcutaneous electrical stimulation electrode, single-use
Primary Device ID10816864020064
NIH Device Record Key33a825dd-f7be-42fb-b799-e2d7735cb84c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonigel Ultrasound Gel Couplants
Version Model Number1853
Catalog Number1853
Company DUNS008513913
Company NameMETTLER ELECTRONICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *No

Device Identifiers

Device Issuing AgencyDevice ID
GS110816864020064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-19
Device Publish Date2017-01-26

On-Brand Devices [Sonigel Ultrasound Gel Couplants]

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

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