FDA UDI
In Commercial Distribution
🇺🇸 United States
Porges Coloplast
DI: 05708932730150
·
Model: RAC018
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Porges Coloplast
- Primary DI
- 05708932730150
- Version / Model
- RAC018
- Catalog Number
- RAC018
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 1
- Public Version Date
- 2020-07-10
- Public Version Status
- New
- Public Device Record Key
- 9624a82a-834e-4f5a-9d2f-631523c7f78a
Device Description
Chiba puncture needles percutaneous nephrostomy set, 18G (ø 1.3 mm), 20 cm, Stainless steel
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 |
|---|---|---|---|---|
| 61503 | Nephrostomy catheter introduction needle | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05708932730167 | GS1 | Retail box | 5 | In Commercial Distribution | |
| Primary | 05708932730150 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 20 | Centimeter | |
| Needle Gauge | 18 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light in a cool and dry place