Identity
- Trade Name
- Needle EUDAMEDFDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- Guidewire Introducer Needle EUDAMEDNeedle FDA UDI
- Model / Reference
- NDL-100-XX EUDAMEDNDL-100-17 EUDAMEDFDA UDI
- Description
- Needle FDA UDI
Identifiers
- Catalog Number
- NDL-100-17 FDA UDI
- Primary DI / UDI-DI
- 00841268102637 EUDAMEDFDA UDI
- Basic UDI-DI
- 08412681IntroducerNDLBC EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- A019013 PERCUTANEOUS NEEDLES EUDAMED
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 870.4500 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
Yes
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
- Needle Gauge — 21 Gauge FDA UDI
Needle by Galt Medical Corp. — Class IIa — 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 | 08412681IntroducerNDLBC | 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 3b2ce060-7ca3-4528-a3f6-0dd0b47ea787 61 fields · synced Oct 6, 2026
- FDA UDI 85b5667c-9891-450c-ab7a-cab9d75949f7 36 fields · synced May 30, 2026