Identity
- Trade Name
- Mammosite Cavity Evaluation Device Kit (CED) FDA UDI
- Generic Name
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- MCEDII TRAY, POST-STERILE FDA UDI
- Model / Reference
- 926000 FDA UDI
- Description
- MCEDII TRAY, POST-STERILE FDA UDI
Identifiers
- Catalog Number
- 926000 FDA UDI
- Primary DI / UDI-DI
- 15420045505018 FDA UDI
- 510(k) Number
- K081179 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast brachytherapy system applicator, remote-afterloading
Mammosite Cavity Evaluation Device Kit (CED) by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast brachytherapy system applicator, remote-afterloading.
- Best Medical International — Best Medical International, Inc. · Class II
- ATEC — Hologic, Inc. · Class I
- ATEC — Hologic, Inc. · Class I
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 df1582ee-3310-4b75-8d2c-ce66a3b7b871 36 fields · synced May 30, 2026