Bexa Pressure Mapping System

GUDID 00860000501729

Breast lesion documentation system

SURE INC.

Electronic clinical breast examination system
Primary Device ID00860000501729
NIH Device Record Keyd03c2045-36b0-4a12-826e-715cd552c254
Commercial Distribution StatusIn Commercial Distribution
Brand NameBexa Pressure Mapping System
Version Model Number1885
Company DUNS116944848
Company NameSURE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com
Phone(833) 787-3462
Emailinfo@mybexa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000501729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKASystem, Documentation, Breast Lesion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-05
Device Publish Date2021-10-28

Devices Manufactured by SURE INC.

00860000501712 - SureTouch Mobile Pressure Mapping System2021-11-05 Breast lesion documentation system
00860000501729 - Bexa Pressure Mapping System2021-11-05Breast lesion documentation system
00860000501729 - Bexa Pressure Mapping System2021-11-05 Breast lesion documentation system

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