EsoSure 100001
GUDID B2271000010
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
Intraluminal oesophageal retractor| Primary Device ID | B2271000010 |
| NIH Device Record Key | a0d3a789-617d-4f49-afa8-3358f9fe3f62 |
| 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 |
Customer Support Contacts
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com | |
| Phone | 203-756-2111 |
| info@smarthealth-care.com |
Device Dimensions
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
| Outer Diameter | 0.052 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B2271000010 [Primary] |
FDA Product Code
| GAD | Retractor |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
[B2271000010]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-29 |
Devices Manufactured by NORTH EAST SCIENTIFIC INC
| B227RS889011 - NES Reprocessed .035 Stryker Catheter | 2024-08-26 NES Reprocessed .035 IVUS reprocessed for Stryker (SSS) |
| B227R85900PST1 - NES Reprocessed Eagle Eye Platinum Short Tip Stryker | 2024-08-23 NES Reprocessed Eagle Eye Platinum Short Tip Catheter reprocessed for Stryker (SSS) |
| B227RS014R1 - NES Reprocessed .014 Stryker Catheter | 2024-08-23 NES Reprocessed .014 IVUS Catheter manufactured for Stryker (SSS) |
| B227RS85900P1 - NES Reprocessed Eagle Eye Platinum Long Tip Stryker | 2024-08-23 NES Reprocessed Eagle Eye Platinum Long Tip Catheter manufactured for Stryker (SSS) |
| B227NRP1301 - NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP1302 - NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP1303 - NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
| B227NRP3681 - NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter | 2023-09-25 |
Trademark Results [EsoSure]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.