QLRAD
GUDID 08719326258218
RectalPro75
QLRAD INTERNATIONAL LTD
Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter Prostate immobilization balloon catheter 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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| Phone | +13054378550 |
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| Phone | +13054378550 |
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| Phone | +13054378550 |
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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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