Identity
- Trade Name
- Dilator EUDAMEDFDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Dilator EUDAMEDFDA UDI
- Model / Reference
- DIL-XXX-XX EUDAMEDDIL-615-52 EUDAMEDFDA UDI
- Description
- Dilator FDA UDI
Identifiers
- Catalog Number
- DIL-615-52 FDA UDI
- Primary DI / UDI-DI
- 00841268107045 EUDAMEDFDA UDI
- Basic UDI-DI
- 08412681SterileDilatorCM EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable 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
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Category: Fascial tissue dilator, single-use
Dilator 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08412681SterileDilatorCM | Class IIa | Active |
| 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 33dcbfeb-6a37-431d-87df-56af6ea710db 61 fields · synced Jun 20, 2026
- FDA UDI 610c2a29-56aa-421c-ab80-240842c22ab3 36 fields · synced May 30, 2026