FDA-Device2020-08-26Class II
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
Pharmaceutical Innovations, Inc.
Hazard
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
Sold states
US Nationwide distribution including in the state of Nevada.
Affected count
tbd
Manufactured in
897 Frelinghuysen Ave, N/A, Newark, NJ, United States
Products
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2830-2020Don't want to check this manually?
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