AccessGUDID - DEVICE: EsoSure (00850044399048)

GUDID

Device Identifier (DI) Information

Brand Name: EsoSure
Version or Model: 100001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100001
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: 00850044399048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use
Previous DI: B2271000010

Device Description: The EsoSure Esophageal Retractor is intended to move the esophagus.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62204	Intraluminal oesophageal retractor	A hand-held manual instrument intended to be orally introduced into the oesophagus during thoracic surgery to mechanically divert the oesophagus away from the site of surgery, to facilitate surgical site access and to help prevent injury. It is available in a variety of forms (e.g., curved metal wire, metal rod with balloon). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.109 Inch

Device Record Status

Public Device Record Key: f2af6462-2515-47af-abd9-7a85b95c58c2
Public Version Date: May 29, 2025
Public Version Number: 1
DI Record Publish Date: May 21, 2025