Cetro America US Transducer for IM76/AM66

GUDID 00852519007007

Replacement ultrasound transducer for Advanced Medical Systems IM76/AM66 model fetal monitor.

CETRO AMERICA INC

Cardiotocograph
Primary Device ID00852519007007
NIH Device Record Key88599900-6b83-44c8-bba3-d0026d186f4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCetro America US Transducer for IM76/AM66
Version Model Number8031010
Company DUNS196275197
Company NameCETRO AMERICA 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com
Phone12032940121
Emailadmin@cetroamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852519007007 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by CETRO AMERICA INC

00852519007250 - Cetro America Toco Transducer for IM76/AM662020-10-02 Replacement Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM76/AM66 fetal monitors.
00852519007267 - Cetro America Toco Transducer for IM77/AM672020-10-02 Replacement Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM77/AM67 fetal monitors.
00852519007274 - Cetro America Toco Transducer for HP 1350+2020-10-02 Replacement Toco Transducer for HP/Philips model HP1350+ fetal monitors.
00852519007281 - Cetro America Toco Transducer for all Coro models2020-10-02 Replacement Toco Transducer for all models of Corometrics brand fetal monitors.
00852519007298 - Cetro America Toco Transducer for FC, FS, Fetacare2020-10-02 Replacement Toco Transducer for FC, FS, Fetacare
00852519007304 - Cetro America Toco Transducer for IM76/AM66, Waterproof2020-10-02 Replacement Waterproof Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM76/AM66 fetal monitors.
00852519007311 - Cetro America Toco Transducer for IM77/AM67, Waterproof2020-10-02 Replacement Waterproof Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM77/AM67 fetal monitors.
00852519007328 - Cetro America Toco Transducer for HP 1350+, Waterproof2020-10-02 Replacement Waterproof Toco Transducer for HP/Philips model HP1350+ fetal monitors.

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