Identity
- Trade Name
- MPM Medical Supply (Private Label) FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- 20GA X 10CM (Breast Localization Needle With Two Wires) FDA UDI
- Model / Reference
- KOP2010 FDA UDI
- Description
- 20GA X 10CM (Breast Localization Needle With Two Wires) FDA UDI
Identifiers
- Catalog Number
- KOP2010 FDA UDI
- Primary DI / UDI-DI
- 00859013006062 FDA UDI
- 510(k) Number
- K863848 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: Mammographic stereotactic biopsy system
MPM Medical Supply (Private Label) by Manan Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
- ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- Eviva — Hologic, Inc. · Class I
- ENCOR® — SENORX, INC. · Class II
- Mammotome — Devicor Medical Products, Inc. · Class II
- Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Manan Medical Products, Inc.
Sources (1)
- FDA UDI 135c0161-6468-4982-adf4-bdf1614b8a93 37 fields · synced Jun 8, 2026