QLRAD
GUDID 08719326258218
RectalPro75
QLRAD INTERNATIONAL LTD
Prostate immobilization balloon catheter| Primary Device ID | 08719326258218 |
| NIH Device Record Key | dc5c9081-4c3b-414d-8af0-4ca45ff4b225 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QLRAD |
| Version Model Number | 105.1014 |
| Company DUNS | 534509598 |
| Company Name | QLRAD INTERNATIONAL LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +13054378550 |
| awinkel@qlrad.com | |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08719326258201 [Primary] |
| GS1 | 08719326258218 [Package] Contains: 08719326258201 Package: [100 Units] In Commercial Distribution |
| GS1 | 08719326258225 [Package] Contains: 08719326258201 Package: box [50 Units] In Commercial Distribution |
| GS1 | 08719326258232 [Package] Contains: 08719326258201 Package: box [100 Units] In Commercial Distribution |
| GS1 | 08719326258249 [Package] Contains: 08719326258225 Package: Box [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180478
FDA Product Code
| PCT | Prostate immobilizer rectal balloon |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-06 |
| Device Publish Date | 2020-09-28 |
On-Brand Devices [QLRAD]
| 08719326258218 | RectalPro75 |
| 08719326258287 | RectalPro75, switch valve LL with 100 cc Syringe |
| 08719326258256 | RectalPro75 |
| 08720892233035 | Inframammary Fold Breast Wedge Large |
| 08720892233004 | Inframammary Fold Breast Wedge Small |
Trademark Results [QLRAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QLRAD 88205077 not registered Live/Pending |
QLRAD NEDERLANDS BV 2018-11-26 |
 QLRAD 85254385 4218697 Dead/Cancelled |
QLRAD B.V. 2011-03-01 |
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