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Ultraflex™ Esophageal NG

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Ultraflex™ Esophageal NG FDA UDI
Generic Name
Bare-metal oesophageal stent, non-sterile FDA UDI
Device Name
Distal Release Stent System FDA UDI
Model / Reference
M00513710 FDA UDI
Description
Distal Release Stent System FDA UDI

Identifiers

Primary DI / UDI-DI
08714729716136 FDA UDI
FDA Product Code
ESW FDA UDI
GMDN Term
Bare-metal oesophageal stent, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bare-metal oesophageal stent, non-sterile

Ultraflex™ Esophageal NG by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal oesophageal stent, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 73172db2-9695-4dea-9d4f-fbfbb8eb9839 34 fields · synced May 30, 2026