FDA UDI
In Commercial Distribution
🇺🇸 United States
ClosureRFS™
DI: 00763000723293
·
Model: RFS2-6-12
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClosureRFS™
- Primary DI
- 00763000723293
- Version / Model
- RFS2-6-12
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-19
- Public Version
- 1
- Public Version Date
- 2024-05-27
- Public Version Status
- New
- Public Device Record Key
- 1ec809b6-f276-430b-878b-6457b45d4696
Device Description
STYLET RFS2-6-12 CLOSUREFAST
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62232 | Peripheral vascular radio-frequency ablation catheter | A sterile, rigid, hand-held luminal device intended to be percutaneously introduced into the peripheral vasculature as the distal component of a radio-frequency ablation system, to deliver radio-frequency current, in a bipolar configuration, for ablation of venous tissue to treat venous reflux disease (varicose veins). It typically includes an inner trocar/stylet to assist introduction and is maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000723293 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052003 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum electrode diameter: 6 Fr | ||
| Length | 12.0 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the device in a dry area away from sunlight.