FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Symphony Centesis Drainage Kit
DI: 00817640020028
·
Model: CTK-6
·
URESIL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Symphony Centesis Drainage Kit
- Primary DI
- 00817640020028
- Version / Model
- CTK-6
- Catalog Number
- CTK-6
- Company Name
- URESIL, LLC
- Labeler DUNS
- 192559557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-11
- Public Version
- 3
- Public Version Date
- 2020-01-17
- Public Version Status
- Update
- Public Device Record Key
- 1b5efe70-725e-41f4-b586-adbacd56accd
- Distribution End Date
- 2020-01-16
Device Description
Symphony Centesis Drainage Kit 6F
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33403 | Pleurocentesis/paracentesis kit | A collection of sterile surgical devices intended for acute (i.e., non-indwelling) therapeutic or diagnostic aspiration of fluids or air from the pleural and/or peritoneal cavities. It includes a dedicated needle, syringe, and appropriate support devices (e.g., dressings, drapes); it does not include a drainage catheter and does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817640020022 | GS1 | SHIPPER | 8 | Not in Commercial Distribution | 2020-01-16 |
| Primary | 00817640020028 | GS1 |
Customer Contacts
- Phone
- 800-538-7374
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter | |
| Catheter Gauge | 6 | French |