Identity
- Trade Name
- UltraCore Biopsy Needle EUDAMEDUltraCore™ Biopsy Needle FDA UDI
- Generic Name
- End-cut biopsy gun needle FDA UDI
- Device Name
- UltraCore EUDAMEDUltraCore™ Biopsy Needle 18ga x 20cm FDA UDIUltraCore™ Biopsy Needle 16ga x 20cm FDA UDI
- Model / Reference
- 762616200 EUDAMEDFDA UDI762618200 FDA UDI
- Description
- UltraCore™ Biopsy Needle 18ga x 20cm FDA UDIUltraCore™ Biopsy Needle 16ga x 20cm FDA UDI
Identifiers
- Catalog Number
- 762618200 FDA UDI762616200 FDA UDI
- Primary DI / UDI-DI
- 20886333006476 EUDAMED00886333006373 FDA UDI00886333006472 FDA UDI
- Basic UDI-DI
- B-20886333006476 EUDAMED
- FDA Product Code
- DWO FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER 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
- Netherlands 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: End-cut biopsy gun needle
UltraCore™ Biopsy Needle by Argon Medical Devices, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun needle.
- FAST-CUT B — STERYLAB SRL · Class II
- Palium Needle — M.D.L. S.R.L. · Class I
- FAST-CUT B — STERYLAB SRL · Class II
- FAST-CUT B — STERYLAB SRL · Class II
- FAST-CUT — STERYLAB SRL · Class II
- Palium Needle — M.D.L. S.R.L. · Class I
- FastCutE — M.D.L. S.R.L. · Class I
- Palium Needle — M.D.L. S.R.L. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (3)
- FDA UDI 8f275209-c9ce-43ae-8b34-53f80c87b1df 37 fields · synced Jul 8, 2026
- FDA UDI 7d765552-0004-4975-b055-f40b97368e2a 37 fields · synced May 30, 2026
- EUDAMED 04b68ed9-0948-4413-8774-e11ad274610b 61 fields · synced Jul 8, 2026