E-Z-GEL UltraSound Gel 601001

GUDID 30815112021406

EZ Gel 8oz

Bracco Diagnostics Inc.

Skin topical coupling gel
Primary Device ID30815112021406
NIH Device Record Key7c5711cf-a0c2-4e1a-9ad9-865996339dea
Commercial Distribution StatusIn Commercial Distribution
Brand NameE-Z-GEL UltraSound Gel
Version Model Number601001
Catalog Number601001
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 Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce
Total Volume8 Fluid Ounce

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112021402 [Primary]
GS130815112021406 [Package]
Contains: 10815112021402
Package: [12 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-GEL UltraSound Gel]

30815112021437EZ Gel 5L
30815112021406EZ Gel 8oz

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