FDA UDI
In Commercial Distribution
🇺🇸 United States
SavvyWire
DI: 07540184030026
·
Model: Small
·
Opsens Inc
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SavvyWire
- Primary DI
- 07540184030026
- Version / Model
- Small
- Catalog Number
- F3002
- Company Name
- Opsens Inc
- Labeler DUNS
- 253717946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-13
- Public Version
- 1
- Public Version Date
- 2023-04-21
- Public Version Status
- New
- Public Device Record Key
- 65c6329c-3c9d-4e3d-8706-bc086e8ac1e4
Device Description
Pre-Shaped Pressure Guidewire
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Cardiovascular | 870.1330 | 2 |
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | 870.2870 | 2 |
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | 870.3680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35094 | Cardiac/peripheral vascular guidewire, single-use | A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07540184130023 | GS1 | carton box | 5 | In Commercial Distribution | |
| Primary | 07540184030026 | GS1 | ||||
| Package | 07540184230020 | GS1 | shipping box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-833-677-3671
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213854 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip Diameter: 4.2 cm | ||
| Length | 280 | Centimeter |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- – 54 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.