FDA UDI
In Commercial Distribution
🇺🇸 United States
Total Abscession
DI: H787140010050
·
Model: 14001005
·
ANGIODYNAMICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Total Abscession
- Primary DI
- H787140010050
- Version / Model
- 14001005
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-16
- Public Version
- 3
- Public Version Date
- 2019-02-12
- Public Version Status
- Update
- Public Device Record Key
- e17b2ffd-615e-4788-b3ba-0c1c1b2fe74d
Device Description
14F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
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
- No
- 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 | H787140010055 | HIBCC | BOX | 5 | In Commercial Distribution | |
| Primary | H787140010050 | HIBCC | ||||
| Secondary | 15051684011624 | GS1 |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Centimeter | |
| Catheter Gauge | 14 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 27 Degrees Celsius