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Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps

FDA UDI

Class II (US FDA UDI)

by CenterPoint Systems LLC

Identity

Trade Name
Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps FDA UDI
Generic Name
Flexible video choledochoscope, single-use FDA UDI
Device Name
Single use pancreaticobiliary scope FDA UDI
Model / Reference
DFE-MD-000652 FDA UDI
Description
Single use pancreaticobiliary scope FDA UDI

Identifiers

Primary DI / UDI-DI
00810024670260 FDA UDI
510(k) Number
K233752 FDA UDI
FDA Product Code
FBN FDA UDI
NTN FDA UDI
ODC FDA UDI
GMDN Term
Flexible video choledochoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

Yes

FDA UDI

Category: Endoscope working-channel valve, single-useFlexible video choledochoscope, single-use

Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps by CenterPoint Systems LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Flexible video choledochoscope, single-use.

Cleared under the same submission

K233752 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CenterPoint Systems LLC

Sources (1)

  • FDA UDI e3a610de-bd69-417a-b1db-0ff4b4e04b79 34 fields · synced Jun 9, 2026