DEVICE: EsoSure (B2271000010)

Device Identifier (DI) Information

EsoSure
100001
In Commercial Distribution
100001
NORTH EAST SCIENTIFIC INC
B2271000010
HIBCC

1
608625823 *Terms of Use
The EsoSure Esophageal Retractor is intended to move the esophagus.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Intraluminal oesophageal retractor A sterile, hand-held manual surgical instrument intended to be inserted through an orogastric (or nasogastric) tube to mechanically divert the oesophagus away from the site of surgery during electrical treatments of the heart (e.g., cardiac ablation), to facilitate surgical site access and to help prevent injury to the oesophagus. It is in the form of a metal wire made of memory alloy which curls at body temperature to an S-shape when in place in the oesophagus; typically there is a handle to assist insertion. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GAD Retractor
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FDA Premarket Submission

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

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.052 Inch
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Device Record Status

a0d3a789-617d-4f49-afa8-3358f9fe3f62
March 29, 2018
2
July 29, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
203-756-2111
info@smarthealth-care.com
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