Identity
- Trade Name
- Cervical Applicator Set, Bundle 2 FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, manual FDA UDI
- Device Name
- Cervical Applicator Bundle 2 FDA UDI
- Model / Reference
- 710855 FDA UDI
- Description
- Cervical Applicator Bundle 2 FDA UDI
Identifiers
- Catalog Number
- CG1002 FDA UDI
- Primary DI / UDI-DI
- 00858012005540 FDA UDI
- 510(k) Number
- K123442 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, manual 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Cervical/intrauterine brachytherapy system applicator, manual
Cervical Applicator Set, Bundle 2 by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123442 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA UDI ea5ff3c7-d17f-4d79-9bce-9f915c56c2fc 35 fields · synced Jun 1, 2026