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, 11cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire. FDA UDI
- Model / Reference
- 8984 FDA UDI
- Description
- The Introducer Kit facilitates percutaneous entry of an intravascular device. Model 8983 contains 7F, 11cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20689841 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
- Introducer Sheath Compatibility — 7 French FDA UDILength — 11 Centimeter FDA UDINeedle Gauge — 20 Gauge FDA UDIGuidewire Length — 40 Centimeter 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 0479c353-525e-41c7-aefa-0ce7d95cfcd4 35 fields · synced Jun 8, 2026