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Dreamtome™ RX 49

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
Dreamtome™ RX 49 FDA UDI
Generic Name
ERCP catheter, non-balloon, electrosurgical FDA UDI
Device Name
Sphincterotome FDA UDI
Model / Reference
M00584020 FDA UDI
Description
Sphincterotome FDA UDI

Identifiers

Primary DI / UDI-DI
08714729778240 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
ERCP catheter, non-balloon, electrosurgical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ERCP catheter, non-balloon, electrosurgical

Dreamtome™ RX 49 by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ERCP catheter, non-balloon, electrosurgical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI 936207c5-0a65-40c0-ad00-c5d867c66447 34 fields · synced Jun 1, 2026