Identity
- Trade Name
- QLRAD FDA UDI
- Generic Name
- Prostate immobilization balloon catheter FDA UDI
- Device Name
- RectalPro75 with 100 cc Syringe FDA UDI
- Model / Reference
- 105.1014 FDA UDI
- Description
- RectalPro75 with 100 cc Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08719326258201 FDA UDI
- 510(k) Number
- K180478 FDA UDI
- FDA Product Code
- PCT FDA UDI
- GMDN Term
- Prostate immobilization balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Prostate immobilization balloon catheter
Qlrad by QLRAD international Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostate immobilization balloon catheter.
- IsoLoc — RADIADYNE, L.L.C. · Class II
- IsoLoc — RADIADYNE, L.L.C. · Class II
- QLRAD — QLRAD international Ltd · Class II
Cleared under the same submission
K180478 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 |
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Manufacturer
- Manufacturer
- QLRAD international Ltd
Sources (1)
- FDA UDI dc5c9081-4c3b-414d-8af0-4ca45ff4b225 35 fields · synced Jun 1, 2026