E-Z-SCAN Low Viscosity UltraSound Gel 601003

GUDID 30815112021420

EZ Scan Pack

Bracco Diagnostics Inc.

Skin topical coupling gel
Primary Device ID30815112021420
NIH Device Record Key2bcc40a3-e6d0-4507-9dba-4b382c3a2bbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameE-Z-SCAN Low Viscosity UltraSound Gel
Version Model Number601003
Catalog Number601003
Company DUNS849234661
Company NameBracco Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx
Phone609-514-2200
Emailxx@xx.xx

Device Dimensions

Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021426 [Primary]
GS130815112021420 [Package]
Contains: 10815112021426
Package: [4 Units]
In Commercial Distribution

FDA Product Code

MUIMedia,Coupling,Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

On-Brand Devices [E-Z-SCAN Low Viscosity UltraSound Gel]

30815112021420EZ Scan Pack
30815112021413EZ Scan 8oz Tube

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.