Alatus ALA-45
GUDID 00851546007004
Alatus Vaginal Balloon Packing System Kit
RADIADYNE, L.L.C.
Vaginal speculum, single-use| Primary Device ID | 00851546007004 |
| NIH Device Record Key | 4afb0d97-9885-4eb8-a113-734f27136882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alatus |
| Version Model Number | ALA-45 Unit Tray |
| Catalog Number | ALA-45 |
| Company DUNS | 005744772 |
| Company Name | RADIADYNE, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com | |
| Phone | 281-759-9600 |
| leahroe@radiadyne.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851546007004 [Primary] |
| GS1 | 10851546007001 [Package] Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20851546007008 [Package] Contains: 10851546007001 Package: Shipper Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092534
FDA Product Code
| IYE | Accelerator, Linear, Medical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-12 |
Devices Manufactured by RADIADYNE, L.L.C.
| 20851546007091 - IsoLoc | 2020-01-28 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit |
| 00851546007196 - OARtrac | 2019-07-11 OARtrac Plus Clinical Detector Unit (CDU) |
| 20851546007169 - QC microPSD | 2019-06-14 QC microPSD sensor cable |
| 20851546007619 - Electron microPSD | 2019-05-30 Electron non-sterile microPSD sensor cable |
| 20851546007107 - IsoLoc | 2018-07-27 IsoLoc Prostate Immobilization Treatment Balloon Device Kit |
| 20851546007145 - Photon MicroPSD | 2018-07-27 Photon-calibrated microPSD sensor cable |
| 00851546007158 - QC MicroPSD | 2018-07-27 QC-calibrated microPSD sensor cable |
| 20851546007213 - IsoLoc | 2018-07-27 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit |
Trademark Results [Alatus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALATUS 78706204 3406821 Dead/Cancelled |
Alatus Partners LLC 2005-09-02 |
 ALATUS 78440021 not registered Dead/Abandoned |
ALATUS SYSTEMS, INC. 2004-06-23 |
 ALATUS 77844052 3830802 Live/Registered |
ANGIODYNAMICS, INC. 2009-10-08 |
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