FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nephro-Cath Nephrostomy Drainage Catheter
DI: 00817640021377
·
Model: NCL2-0835HB
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Nephro-Cath Nephrostomy Drainage Catheter
- Primary DI
- 00817640021377
- Version / Model
- NCL2-0835HB
- Catalog Number
- NCL2-0835HB
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-29
- Public Version
- 2
- Public Version Date
- 2023-01-18
- Public Version Status
- Update
- Public Device Record Key
- f4c4cabb-94e8-416c-b029-de3cf8ca49a8
- Distribution End Date
- 2023-01-17
Device Description
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 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
- Yes
- 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 |
|---|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10735 | Nephrostomy catheter | A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817640021374 | GS1 | Dispenser | 5 | Not in Commercial Distribution | 2023-01-17 |
| Primary | 00817640021377 | GS1 | ||||
| Package | 20817640021371 | GS1 | Shipper | 4 | Not in Commercial Distribution | 2023-01-17 |
| Previous | H862NCL20835HB0 | HIBCC |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French | |
| Length | 28 | Centimeter |