Identity
- Trade Name
- Introducer Kit, 7F FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- The Introducer Kit facilitates percutaneous entry of an intravascular device. Model 8983 contains 7F, 7cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire. FDA UDI
- Model / Reference
- 8983 FDA UDI
- Description
- The Introducer Kit facilitates percutaneous entry of an intravascular device. Model 8983 contains 7F, 7cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20689831 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Guidewire Length — 40 Centimeter FDA UDINeedle Gauge — 20 Gauge FDA UDILength — 7 Centimeter FDA UDIIntroducer Sheath Compatibility — 7 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Introducer Kit, 7F by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI 5096f21d-c05d-422c-8fd7-5556c4bef851 35 fields · synced May 30, 2026