FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Safari2
DI: 00816349012280
·
Model: H74939707JPNL0
·
Lake Region Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Safari2
- Primary DI
- 00816349012280
- Version / Model
- H74939707JPNL0
- Catalog Number
- SCMBW-011V
- Company Name
- Lake Region Medical
- Labeler DUNS
- 031108704
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-30
- Public Version
- 2
- Public Version Date
- 2022-11-03
- Public Version Status
- Update
- Public Device Record Key
- 2b0f6ca4-a66f-455d-a1b2-da0af1e42f8c
- Distribution End Date
- 2022-11-02
Device Description
TAVR Guidewire
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
- 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 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00816349012280 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Guidewire Length | 275 | Centimeter | |
| Guidewire Diameter | .035 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place.