Identity
- Trade Name
- 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER FDA UDI
- Generic Name
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- 4.0-5.0 CM CONTURAFLEX MLB CATHETER WITH TRICONCAVE TIP INTRODUCER FDA UDI
- Model / Reference
- B11245 FDA UDI
- Description
- 4.0-5.0 CM CONTURAFLEX MLB CATHETER WITH TRICONCAVE TIP INTRODUCER FDA UDI
Identifiers
- Catalog Number
- B11245 FDA UDI
- Primary DI / UDI-DI
- 15420045505193 FDA UDI
- 510(k) Number
- K081079 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
- Not 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
4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 d9668eec-4119-44b5-9026-dcf43b5de39a 37 fields · synced Jun 6, 2026