E-Z-SCAN Low Viscosity UltraSound Gel 601002

GUDID 30815112020546

EZ Scan 8oz Tube

BRACCO DIAGNOSTICS INC

Topical coupling gel, non-sterile
Primary Device ID30815112020546
NIH Device Record Key2c5c468b-93a0-4677-bb28-f690ab93e6eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameE-Z-SCAN Low Viscosity UltraSound Gel
Version Model Number601002
Catalog Number601002
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110815112020542 [Primary]
GS130815112020546 [Package]
Contains: 10815112020542
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

MUIMedia,Coupling,Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2016-09-23

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

30815112020553EZ Scan Pack
30815112020546EZ Scan 8oz Tube

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.