Galt VTI® Introducer Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Galt VTI® Introducer Set EUDAMEDValved Tearaway Introducer Set FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Valved Tearaway Set Product Family EUDAMEDValved Tearaway Introducer Set FDA UDI
- Model / Reference
- VTI-XXX-XX EUDAMEDVTI-008-16 EUDAMEDFDA UDI
- Description
- Valved Tearaway Introducer Set FDA UDI
Identifiers
- Catalog Number
- VTI-008-16 FDA UDI
- Primary DI / UDI-DI
- 00841268107618 EUDAMEDFDA UDI
- Basic UDI-DI
- 08412681Galt-VTIR5 EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 16 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Galt VTI® Introducer Set by Galt Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08412681Galt-VTIR5 | Class IIa | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Galt Medical Corp.
- EUDAMED SRN
- US-MF-000001777
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c57d6719-6056-4b2c-b7fa-826e992048d7 61 fields · synced Jun 17, 2026
- FDA UDI cd569399-6867-4475-8d66-061c0fc8029d 36 fields · synced May 30, 2026