Identity
- Trade Name
- ATEC Canister EUDAMEDATEC FDA UDI
- Generic Name
- General tissue specimen container IVD, fixative/saline FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System EUDAMEDSUCTION CANISTER W/ LID FDA UDI
- Model / Reference
- ATEC Canister EUDAMEDFDA UDI
- Description
- SUCTION CANISTER W/ LID FDA UDI
Identifiers
- Catalog Number
- ATEC Canister FDA UDI
- Primary DI / UDI-DI
- 15420045503182 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455ATECEVIVACCESS8K EUDAMED
- Unit of Use DI
- 05420045503185 EUDAMED
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- General tissue specimen container IVD, fixative/saline FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General tissue specimen container IVD, fixative/saline
Atec by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K042290 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI 0051939a-cf24-4f7a-be27-8743fca669a0 36 fields · synced Jun 14, 2026
- EUDAMED afbaad2f-8f46-4e6f-9fb7-bfa83f70d9c9 61 fields · synced Jun 14, 2026