Identity
- Trade Name
- SuperCore Biopsy Instrument EUDAMEDSuperCore™ Biopsy Instrument FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- SuperCore EUDAMEDSuperCore™ Biopsy Instrument with Co-Axial Introducer Needle FDA UDI
- Model / Reference
- 701214150 EUDAMEDFDA UDI701220090 FDA UDI
- Description
- SuperCore™ Biopsy Instrument with Co-Axial Introducer Needle FDA UDI
Identifiers
- Catalog Number
- 701220090 FDA UDI701214150 FDA UDI
- Primary DI / UDI-DI
- 20886333005998 EUDAMED00886333006069 FDA UDI00886333005994 FDA UDI
- Basic UDI-DI
- B-20886333005998 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 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 handpiece/needle
SuperCore™ Biopsy Instrument by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as End-cut biopsy gun handpiece/needle.
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- SemiCut — M.D.L. S.R.L. · Class II
- Themy — M.D.L. S.R.L. · Class II
- SemiCut Coax. — M.D.L. S.R.L. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (3)
- FDA UDI 14b6e448-a17e-4701-a941-f3781fcdd242 36 fields · synced Jul 8, 2026
- FDA UDI 7865bf08-f930-472c-bedb-77be6c7506e3 36 fields · synced May 30, 2026
- EUDAMED b53e7412-d8a2-4899-a832-4ef23c10d993 61 fields · synced Jul 8, 2026