SureTouch Mobile Pressure Mapping System

GUDID 00860000501712

Electronic clinical breast examination system

Primary Device ID	00860000501712
NIH Device Record Key	be3a1ab5-312f-43dd-ac94-c4eea79e5c57
Commercial Distribution Status	In Commercial Distribution
Brand Name	SureTouch Mobile Pressure Mapping System
Version Model Number	1885
Company DUNS	116944848
Company Name	SURE INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860000501712 [Primary]

NKA	System, Documentation, Breast Lesion

Steralize Prior To Use	false
Device Is Sterile	false

00860000501712 - SureTouch Mobile Pressure Mapping System	2021-11-05Breast lesion documentation system
00860000501712 - SureTouch Mobile Pressure Mapping System	2021-11-05 Breast lesion documentation system
00860000501729 - Bexa Pressure Mapping System	2021-11-05 Breast lesion documentation system