STERILE AQUASONIC 01-01

GUDID 00855683006005

Sterile Aquasonic 100 Ultrasound transmission gel 20 g over wrapped foil pouch

PARKER LABORATORIES INC

Electrode conductive medium
Primary Device ID00855683006005
NIH Device Record Key26d82c8b-699d-42a1-b1f5-a12cedfbc7f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERILE AQUASONIC
Version Model NumberULTRASOUND TRANSMISSION GEL
Catalog Number01-01
Company DUNS002449593
Company NamePARKER LABORATORIES INC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com
Phone1-973-276-9500
EmailNbuchalter@parkerlabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855683006005 [Primary]
GS110855683006002 [Package]
Package: BOX [48 Units]
In Commercial Distribution
GS120855683006009 [Package]
Contains: 10855683006002
Package: BOX [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2016-12-19

On-Brand Devices [STERILE AQUASONIC]

00855683006005Sterile Aquasonic 100 Ultrasound transmission gel 20 g over wrapped foil pouch
20855683006023Sterile Aquasonic 100 Ultrasound Transmission gel, 20g packette

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