FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VSI Radial™ introducer sheath
DI: M20690100
·
Model: 9010
·
Vascular Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VSI Radial™ introducer sheath
- Primary DI
- M20690100
- Version / Model
- 9010
- Company Name
- Vascular Solutions, Inc.
- Labeler DUNS
- 008999906
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 5
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 6aa13ffa-147a-40cb-af21-0d6da0a253fe
- Distribution End Date
- 2019-06-30
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M20690100 | HIBCC | ||||
| Package | M20690101 | HIBCC | Box | 5 | Not in Commercial Distribution | 2019-06-30 |
Customer Contacts
- Phone
- 888-240-6001
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.035" Kit | ||
| Catheter Gauge | 6 | French |