FDA UDI
In Commercial Distribution
🇺🇸 United States
Chole-Cath Biliary Drainage Catheter
DI: 00817640021148
·
Model: CCL2-0850HBX
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Chole-Cath Biliary Drainage Catheter
- Primary DI
- 00817640021148
- Version / Model
- CCL2-0850HBX
- Catalog Number
- CCL2-0850HBX
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-28
- Public Version
- 1
- Public Version Date
- 2022-05-06
- Public Version Status
- New
- Public Device Record Key
- 988981f1-c690-443d-96db-c78b14c52ca5
Device Description
HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 8F
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGE | Catheter, Biliary, Diagnostic | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10696 | Biliary drain | A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817640021145 | GS1 | Dispenser | 5 | In Commercial Distribution | |
| Primary | 00817640021148 | GS1 | ||||
| Package | 20817640021142 | GS1 | Shipper | 4 | In Commercial Distribution | |
| Previous | H862CCL20850HBX0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923096 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French | |
| Length | 41 | Centimeter |