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Chole-Cath Biliary Drainage Catheter
FDA UDIClass 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 AND DEPTH MARKS, 8F FDA UDI
- Model / Reference
- CCL2T-0850HB FDA UDI
- Description
- HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F FDA UDI
Identifiers
- Catalog Number
- CCL2T-0850HB FDA UDI
- Primary DI / UDI-DI
- 00817640021162 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
- 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 — 8 French FDA UDILength — 41 Centimeter FDA UDI
Category: Biliary drain
Chole-Cath Biliary Drainage Catheter by Uresil Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K923096 also covers:
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
- Chole-Cath Biliary Drainage Catheter — Uresil Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Uresil Corp.
Sources (1)
- FDA UDI 06732909-78f2-4c1d-94ec-3be529ecb2f4 37 fields · synced May 30, 2026