| Primary Device ID | 00860001700107 |
| NIH Device Record Key | ba35886a-713a-4c51-a211-6149edc5350a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Collim-Aid |
| Version Model Number | CA2 |
| Company DUNS | 102370137 |
| Company Name | Reina Imaging |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com | |
| Phone | 8153568181 |
| treina@reinaimaging.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001700107 [Primary] |
| KPY | Shield, Protective, Personnel |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 00860001700107 - Collim-Aid | 2023-06-16The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. |
| 00860001700107 - Collim-Aid | 2023-06-16 The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to rad |
| 00860001700169 - Stitching Platform with Handles/ Clear Stitching Stand | 2023-06-16 Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping p |
| 00860001700176 - Weight Bearing DRP Holders | 2023-06-16 Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor |
| 00860001700121 - Trans-Former | 2019-11-06 Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. I |
| 00860001700183 - Protect-A-Grid | 2019-11-06 The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may als |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLLIM-AID 90624648 not registered Live/Pending |
REINA IMAGING 2021-04-05 |