Identity
- Trade Name
- CUSTOM HEALTHCARE SYSTEMS INC FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Model / Reference
- B9-16261 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811870031830 FDA UDI
- FDA Product Code
- LRO FDA UDI
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Mammographic stereotactic biopsy system
Custom Healthcare Systems Inc by Manus Medical, LLC — Class II — 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
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
- Manus Medical, LLC
Sources (1)
- FDA UDI c0ca24d6-0051-4b3b-93e8-b16d9e98a9c9 32 fields · synced Jun 8, 2026