Identity
- Trade Name
- STRADIS FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- INTRODUCER KIT FDA UDI
- Model / Reference
- SS20220 FDA UDI
- Description
- INTRODUCER KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- M752SS202201 FDA UDI
- 510(k) Number
- K043525 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Haemostasis valve 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
Yes
FDA UDI
Category: Haemostasis valve
Stradis by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemostasis valve.
- AccessPLUS™ — Merit Medical Systems, Inc. · Class II
- FLO30™ — Merit Medical Systems, Inc. · Class II
- VSI Micro-HV Introducer Kit — Galt Medical Corp. · Class II
- GUARDIAN — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Honor® — Merit Medical Systems, Inc. · Class II
- AVANTI — Cordis Corp. · Class II
Cleared under the same submission
K043525 also covers:
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- Elite HV® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI De-Clot Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Micro-HV Introducer Kit — Galt Medical Corp.
- VSI Radial Micro-HV Introducer Kit — Galt Medical Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stradis Medical, Llc
Sources (1)
- FDA UDI 3505597d-cfd8-406e-a1bb-5fd64457ffb4 35 fields · synced Jun 8, 2026