Identity
- Trade Name
- StandTall EUDAMEDFDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- StandTall EUDAMEDSheath Extender and Securement Clasp, 25cm FDA UDI
- Model / Reference
- ST0025L EUDAMEDFDA UDI
- Description
- Sheath Extender and Securement Clasp, 25cm FDA UDI
Identifiers
- Catalog Number
- ST0025L FDA UDI
- Primary DI / UDI-DI
- 10853714008018 EUDAMED00853714008011 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853714008ST0000WG EUDAMED
- FDA Product Code
- DTL FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
- Lumen/Inner Diameter — 2.7 Millimeter FDA UDI
StandTall by Radux Devices, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0853714008ST0000WG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radux Devices, Inc
- EUDAMED SRN
- US-MF-000034745
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED 71cdf233-c5e1-49dc-9414-68bf66bdc20b 61 fields · synced Jun 20, 2026
- EUDAMED 3fea99d5-b166-4509-851f-0ad008284610 61 fields · synced May 19, 2026
- FDA UDI 848807e6-9441-455d-b3dd-14126a9668fd 36 fields · synced May 30, 2026