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Chole-Cath Biliary Drainage Catheter

FDA UDI

Class II (US FDA UDI)

by Uresil Corp.

Identity

Trade Name
Chole-Cath Biliary Drainage Catheter FDA UDI
Generic Name
Biliary drain FDA UDI
Device Name
HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 12F FDA UDI
Model / Reference
CCL2T-1250HBX FDA UDI
Description
HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 12F FDA UDI

Identifiers

Catalog Number
CCL2T-1250HBX FDA UDI
Primary DI / UDI-DI
H862CCL2T1250HBX0 FDA UDI
510(k) Number
K923096 FDA UDI
FDA Product Code
FGE FDA UDI
GMDN Term
Biliary drain FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5010 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Dimensions & Sizes

Size
Catheter Gauge — 12 French FDA UDI
Length — 40 Centimeter FDA UDI

Chole-Cath Biliary Drainage Catheter by Uresil Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K923096 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Uresil Corp.

Sources (1)

  • FDA UDI e9e4d01c-c6f4-413d-88c3-c91501c0abcf 38 fields · synced May 30, 2026