EsoSure 100001

GUDID 00850044399048

Intraluminal oesophageal retractor

Primary Device ID	00850044399048
NIH Device Record Key	f2af6462-2515-47af-abd9-7a85b95c58c2
Commercial Distribution Status	In Commercial Distribution
Brand Name	EsoSure
Version Model Number	100001
Catalog Number	100001
Company DUNS	608625823
Company Name	NORTH EAST SCIENTIFIC INC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	00850044399048 [Primary]
HIBCC	B2271000010 [Previous]

Retractor

Steralize Prior To Use	false
Device Is Sterile	true

B2271000010	The EsoSure Esophageal Retractor is intended to move the esophagus.
00850044399048	The EsoSure Esophageal Retractor is intended to move the esophagus.

Mark Image Registration \| Serial	Company Trademark Application Date
ESOSURE 88714344 not registered Live/Pending	Northeast Scientific, Inc. 2019-12-04
ESOSURE 88489562 not registered Live/Pending	PAVmed Inc. 2019-06-26
ESOSURE 88489556 not registered Live/Pending	PAVmed Inc. 2019-06-26