HC50 TRANSFORMER X-095.16.320

GUDID 00192896071780

HC50 TRANSFORMER

SONTEC INSTRUMENTS, INC.

General physical examination set
Primary Device ID00192896071780
NIH Device Record Keye6f658be-35a4-41dd-9b01-cfe4fa685552
Commercial Distribution StatusIn Commercial Distribution
Brand NameHC50 TRANSFORMER
Version Model NumberX-095.16.320
Catalog NumberX-095.16.320
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800) 821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896071780 [Primary]

FDA Product Code

ETFUNIT, EXAMINING/TREATMENT, ENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896071780]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-18
Device Publish Date2018-09-17

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