AccessGUDID - DEVICE: EsoSure (B2271000010)

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

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.052 Inch

Device Record Status

Public Device Record Key: a0d3a789-617d-4f49-afa8-3358f9fe3f62
Public Version Date: April 04, 2023
Public Version Number: 3
DI Record Publish Date: July 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 203-756-2111
Email: info@smarthealth-care.com

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