Identity
- Trade Name
- EXEL SPINAL NDL 28GX3-1/2" EUDAMEDFDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- Spinal Needle EUDAMEDEXEL SPINAL NDL 28GX3-1/2", 50/BOX,100/CS, 4CS/CRTN FDA UDI
- Model / Reference
- 26974 EUDAMEDFDA UDI
- Description
- EXEL SPINAL NDL 28GX3-1/2", 50/BOX,100/CS, 4CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26974 FDA UDI
- Primary DI / UDI-DI
- 00020221269741 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221269741 EUDAMED
- 510(k) Number
- K895771 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A01030101 SPINAL ANAESTHESIA NEEDLES AND KITS EUDAMED
- GMDN Term
- Spinal needle, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Exel Spinal Ndl 28gx3-1/2" by Exelint International, Co. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00020221269741 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 28685ab9-e0d2-4ee7-9d07-a94af05efe5f 61 fields · synced Jul 22, 2026
- FDA UDI 19519ea9-deb0-46e8-9d77-45b0d01fab3a 37 fields · synced May 30, 2026