Ultraphonic (250ml Bottle)

GUDID 00858703006252

Ultrasound Gel

ACCELERATED CARE PLUS CORP

Coupling gel, non-sterile
Primary Device ID00858703006252
NIH Device Record Key7c4483fe-eca9-42a5-936f-cec84e0b8cc9
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraphonic (250ml Bottle)
Version Model Number45539
Company DUNS828331616
Company NameACCELERATED CARE PLUS CORP
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 Usefalse
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

Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com
Phone800-350-1100
Emailcustomersupport@acplus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858703006252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-06

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B179OMNI13E87E4 - OmnisEMG2023-09-14 Biomechanical function analysis / interactive rehabilitation system
00858703006337 - Synchrony Dysphagia Solutions by ACP2023-09-11 Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
00858703006351 - OmniVR Elite2023-09-11 Virtual display rehabilitation system
04041925002799 - OmniCycle Elite2023-09-11 Powered exercise therapy bicycle
04041925002805 - OmniStand2023-09-11 Exerciser, non-measuring for stroke rehabilitation

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