Identity
- Trade Name
- ImmobiLoc FDA UDI
- Generic Name
- Rectosphincteric balloon FDA UDI
- Device Name
- ImmobiLoc Gas Release Prostate Immobilization Treatment Balloon Device Kit FDA UDI
- Model / Reference
- ILG-90F FDA UDI
- Description
- ImmobiLoc Gas Release Prostate Immobilization Treatment Balloon Device Kit FDA UDI
Identifiers
- Catalog Number
- ILG-90F FDA UDI
- Primary DI / UDI-DI
- 00851546007059 FDA UDI
- 510(k) Number
- DEN130036 FDA UDI
- FDA Product Code
- PCT FDA UDI
- GMDN Term
- Rectosphincteric balloon 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Rectosphincteric balloon
ImmobiLoc by Radiadyne, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rectosphincteric balloon.
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Cleared under the same submission
DEN130036 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
- Radiadyne, L.l.c.
Sources (1)
- FDA UDI a6264d56-501a-4161-ab28-cf1bdf315511 37 fields · synced May 30, 2026