Identity
- Trade Name
- EsoSure FDA UDI
- Generic Name
- Intraluminal oesophageal retractor FDA UDI
- Device Name
- The EsoSure Esophageal Retractor is intended to move the esophagus. FDA UDI
- Model / Reference
- 100001 FDA UDI
- Description
- The EsoSure Esophageal Retractor is intended to move the esophagus. FDA UDI
Identifiers
- Catalog Number
- 100001 FDA UDI
- Primary DI / UDI-DI
- B2271000010 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Intraluminal oesophageal retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.052 Inch FDA UDI
Category: Intraluminal oesophageal retractor
EsoSure by Northeast Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraluminal oesophageal retractor.
- DV8® Retractor — Manual Surgical Sciences, L. L. C. · Class I
- DV8® Retractor — Manual Surgical Sciences, L. L. C. · Class I
- EsoSure — NORTHEAST SCIENTIFIC, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Northeast Scientific, Inc.
Sources (1)
- FDA UDI a0d3a789-617d-4f49-afa8-3358f9fe3f62 37 fields · synced May 30, 2026