Ameritus Transducer ATG303-TB

GUDID 10817522010724

transducer

KENTEC MEDICAL, INC.

Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor
Primary Device ID10817522010724
NIH Device Record Key328ff918-bf10-4702-937a-94030116ca7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmeritus Transducer
Version Model NumberATG303-TB
Catalog NumberATG303-TB
Company DUNS066175613
Company NameKENTEC MEDICAL, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com
Phone949-863-0810
Emailkjrooks@kentecmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110817522010724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-11-28
Device Publish Date2016-09-21

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