FDA.reportPublic FDA data

EsoSure

Primary DI
00850044399048
Brand
EsoSure
Company
NORTH EAST SCIENTIFIC INC
Model
100001
Catalog number
100001
Device description
The EsoSure Esophageal Retractor is intended to move the esophagus.
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2271000010PreviousHIBCC0
00850044399048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044399048008500443990488500443990480850044399048

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal oesophageal retractorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.109Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-756-2111sales@nescientific.com

Regulatory Flags#

DUNS number
608625823
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B227RS014R1NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2024-08-15
00850044399000NES Reprocessed Varicose Vein RF CatheterCF7-7-60R-CF7-7-602025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterCF7-7-100R-CF7-7-1002025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterCF7-3-60R-CF7-3-602025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)R-RFS2-6-12R-RFS2-6-122025-05-21
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterR-410-152R-410-1522025-05-21
00850044399062NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterR-410-154R-410-1542025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterR-420-006R-420-0062025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterR-420-159R-420-1592025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterR-417-152R-417-1522025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterR-417-156R-417-1562025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterR-414-151R-414-1512025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterR-414-159R-414-1592025-05-21
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterR-88901R-889012025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterR-014RR-014R2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterR-85900P2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipR-85900PST2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerR-S85900PR-S85900P2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerR-S85900PSTR-S85900PST2025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B382SD9141781200Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD91417912190Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B8039018650ORTHOMEDORTHO-MED, INC.GAD2026-10-27
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437169MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776439781MilleniumAvalign Technologies, Inc.GAD2026-10-26
00190776436957MillenniumAvalign Technologies, Inc.GAD2026-10-23
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00190776437022MillenniumAvalign Technologies, Inc.GAD2026-10-23
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19