FDA UDI
In Commercial Distribution
🇺🇸 United States
Symplicity Spyral™
DI: 00763000354466
·
Model: RDN016
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Symplicity Spyral™
- Primary DI
- 00763000354466
- Version / Model
- RDN016
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-30
- Public Version
- 1
- Public Version Date
- 2023-12-08
- Public Version Status
- New
- Public Device Record Key
- 002038bf-d386-4268-85de-9e6ce3a12fb5
Device Description
SPYRAL CATHETER RDN016 US COMMERCIAL
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
- 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 |
|---|---|---|---|---|
| QYI | Ablation catheter, renal denervation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58893 | Renal denervation radio-frequency ablation catheter | A sterile, steerable, thin, flexible tube containing one or more monopolar electrodes intended to be introduced percutaneously into the renal artery to transmit precisely-focused, low-level, radio-frequency (RF) current, from a connected RF generator, to disrupt renal nerves for therapeutic denervation of the kidney; commonly known as renal denervation (RDN). The device has embedded metallic electrodes and may be available in a variety of forms (e.g., deflectable tip, balloon catheter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000354466 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P220026 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1.78 MM Minimum Inner Diameter | ||
| Device Size Text, specify | 1.32 MM Outer Diameter | ||
| Device Size Text, specify | 117 CM Effective Length | ||
| Device Size Text, specify | 19 MM Tip Diameter | ||
| Device Size Text, specify | 6 FR Guide Catheter | ||
| Device Size Text, specify | 0.36 MM Maximum Guidewire Diameter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -35 – 57 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 595 – 1060 millibar