Identity
- Trade Name
- ATEC Introducer FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 9G INTRODUCER LOCALIZATION SET (-OB MODEL) FOR ATEC0914-20MR FDA UDI
- Model / Reference
- ILS 0914-20-OB FDA UDI
- Description
- 9G INTRODUCER LOCALIZATION SET (-OB MODEL) FOR ATEC0914-20MR FDA UDI
Identifiers
- Catalog Number
- ILS 0914-20-OB FDA UDI
- Primary DI / UDI-DI
- 05420045503789 FDA UDI
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
MR Conditional FDA UDI
ATEC Introducer by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042290 also covers:
- ATEC — Hologic, Inc.
- ATEC — Hologic, Inc.
- ATEC — Hologic, Inc.
- ATEC EMERALD — Hologic, Inc.
- ATEC Needle Guide — Hologic, Inc.
- ATEC PEARL — Hologic, Inc.
- ATEC SAPPHIRE — Hologic, Inc.
- ATEC SAPPHIRE 100 — Hologic, Inc.
- ATEC SAPPHIRE25 — Hologic, Inc.
- ATEC Sapphire 200 — Hologic, Inc.
- Eviva Needle Guide — Hologic, Inc.
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
- Hologic, Inc.
Sources (1)
- FDA UDI 61edb7e4-66cd-4c22-9c01-e3cc1ba9e415 37 fields · synced Jun 8, 2026