Identity
- Trade Name
- M-Core FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- Disposable Core Biopsy Needle FDA UDI
- Model / Reference
- MC1825 FDA UDI
- Description
- Disposable Core Biopsy Needle FDA UDI
Identifiers
- Primary DI / UDI-DI
- B567MC18250 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Radiation Sterilization FDA UDI
Category: End-cut biopsy gun handpiece/needle
M-Core by Insert Molding Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun handpiece/needle.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Themy — M.D.L. S.R.L. · Class II
- Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- SemiCut — M.D.L. S.R.L. · Class II
- SuperCore™ Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- SemiCut Coax. — M.D.L. S.R.L. · Class II
- SuperCore Advantage™ — Argon Medical Devices, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Insert Molding Solutions, Inc.
Sources (1)
- FDA UDI 5355aa8f-d0e4-411a-bea6-3de4d9689042 33 fields · synced May 30, 2026