FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nephro-Stent Nephroureteral Stent Catheter
DI: H862NSL2T0822H0
·
Model: NSL2T-0822H
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Nephro-Stent Nephroureteral Stent Catheter
- Primary DI
- H862NSL2T0822H0
- Version / Model
- NSL2T-0822H
- Catalog Number
- NSL2T-0822H
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-09
- Public Version
- 2
- Public Version Date
- 2022-04-29
- Public Version Status
- Update
- Public Device Record Key
- 4d26e7ef-1e10-4262-b811-5b8535cb3275
- Distribution End Date
- 2022-04-28
Device Description
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
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 |
|---|---|---|---|---|
| LJE | Catheter, Nephrostomy | Unknown | U |
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 | H862NSL2T0822H1 | HIBCC | Dispenser | 5 | Not in Commercial Distribution | 2022-04-28 |
| Primary | H862NSL2T0822H0 | HIBCC | ||||
| Package | H862NSL2T0822H2 | HIBCC | Shipper | 4 | Not in Commercial Distribution | 2022-04-28 |
Customer Contacts
- Phone
- 1-800-538-7374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K980889 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8 | French | |
| Length | 22 | Centimeter |