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Palium Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MGC1416Ref MGK12010Ref MGK11412Ref MGK11416Ref MGC1816Ref MGC1616Ref MGK12013Ref MGC1620Ref MGK11213Ref MGK11820Ref MGC1615Ref MGC1810Ref MGK11616Ref MGK11625Ref MGK11816Ref MGC1420
Identity
- Trade Name
- Palium Needle EUDAMEDPaliumNeedle FDA UDI
- Generic Name
- End-cut biopsy gun needle FDA UDI
- Device Name
- Palium Needle EUDAMED10CS-DISP.NEEDLE 18GX200mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI10CS-DISP.NEEDLE 16GX160mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITHBARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI10CS-DISP.NEEDLE 18GX160mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI
- Model / Reference
- MGC1416 EUDAMEDMGK12010 EUDAMEDMGK11412 EUDAMEDMGK11416 EUDAMEDMGC1816 EUDAMEDMGC1616 EUDAMEDMGK12013 EUDAMEDMGC1620 EUDAMEDMGK11213 EUDAMEDMGK11820 EUDAMEDFDA UDIMGC1615 EUDAMEDMGC1810 EUDAMEDMGK11616 EUDAMEDFDA UDIMGK11816 EUDAMEDFDA UDIMGK11625 EUDAMEDMGC1420 EUDAMED
- Description
- 10CS-DISP.NEEDLE 18GX200mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI10CS-DISP.NEEDLE 16GX160mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITHBARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI10CS-DISP.NEEDLE 18GX160mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM.MAGNUM GUN/PALIUM GUN FDA UDI
Identifiers
- Catalog Number
- MGK11820 FDA UDIMGK11616 FDA UDIMGK11816 FDA UDI
- Primary DI / UDI-DI
- 08032986351434 EUDAMED08052440104741 EUDAMED08052440104727 EUDAMED08052440104697 EUDAMED08032986351519 EUDAMED08032986351489 EUDAMED08052440104758 EUDAMED08032986351496 EUDAMED08052440104529 EUDAMED08052440104550 EUDAMEDFDA UDI08058341215241 EUDAMED08032986351502 EUDAMED08052440104659 EUDAMEDFDA UDI08052440101283 EUDAMEDFDA UDI08052440104673 EUDAMED08032986351441 EUDAMED
- Basic UDI-DI
- B-08032986351434 EUDAMEDB-08052440104741 EUDAMEDB-08052440104727 EUDAMEDB-08052440104697 EUDAMEDB-08032986351519 EUDAMEDB-08032986351489 EUDAMEDB-08052440104758 EUDAMEDB-08032986351496 EUDAMEDB-08052440104529 EUDAMEDB-08052440104550 EUDAMEDB-08058341215241 EUDAMEDB-08032986351502 EUDAMEDB-08052440104659 EUDAMEDB-08052440104673 EUDAMEDB-08052440101283 EUDAMEDB-08032986351441 EUDAMED
- FDA Product Code
- MJG FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- End-cut biopsy gun needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 18 Gauge FDA UDILength — 200 Millimeter FDA UDILength — 160 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
Palium Needle by M.d.l. S.r.l. — Class IIa — 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-08032986351434 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (19)
- EUDAMED e03fc084-3686-4d76-b487-f81b3902962b 61 fields · synced Oct 6, 2026
- EUDAMED a95de764-87d1-4ac3-9d57-377409ca6913 61 fields · synced May 16, 2026
- EUDAMED ad52cc6b-2a25-4bb9-9786-567e7c513038 61 fields · synced May 16, 2026
- EUDAMED 416a82ed-19e8-4b5c-93ac-1ac2089e6076 61 fields · synced May 16, 2026
- EUDAMED 2eeb698e-8422-43d0-b6e7-2b50083e9a42 61 fields · synced May 16, 2026
- EUDAMED c5b63d5a-ce94-4d4d-9bbf-98fcd235ee02 61 fields · synced May 16, 2026
- EUDAMED b3b6ffe5-3b93-48f0-9a85-7e4230484947 61 fields · synced May 17, 2026
- EUDAMED e579692c-b202-4710-b99e-798563bc0856 61 fields · synced May 17, 2026
- EUDAMED cbaaebb9-c530-4392-9892-e293de3531c8 61 fields · synced May 18, 2026
- EUDAMED eee9f815-48d0-4b7a-8acb-5dc9f0642fc5 61 fields · synced May 18, 2026
- EUDAMED 6bd0af80-df75-4b61-ba1c-f3df181bc874 61 fields · synced May 18, 2026
- EUDAMED f37ad6d3-3200-453c-b91c-4ec1e1404c18 61 fields · synced May 18, 2026
- FDA UDI 246a3a89-9ec7-49fd-8b90-8e245b1cd1b8 36 fields · synced May 29, 2026
- FDA UDI 487dd166-43b6-4510-b5a5-e8d06db29b79 36 fields · synced May 30, 2026
- FDA UDI 724d50f8-bab2-4fd2-93ac-6b11127bc749 36 fields · synced May 30, 2026
- EUDAMED 4bbdcff2-ba38-45e0-8c1b-b5a48f98ca2f 61 fields · synced Jul 9, 2026
- EUDAMED 49a11013-6e32-4070-8627-f4ba6a434e1d 61 fields · synced Jul 9, 2026
- EUDAMED a589a8aa-3a89-4dfa-89f5-9d09820023db 61 fields · synced Jul 18, 2026
- EUDAMED 2827e7ec-479e-47bf-9c4f-2a49861a91b1 61 fields · synced Jul 31, 2026