| Primary Device ID | 10687225325087 |
| NIH Device Record Key | 552eda9c-f1ca-4677-8fde-92a81b457872 |
| Commercial Distribution Discontinuation | 2020-03-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Gantry Guard |
| Version Model Number | CTG01 |
| Company DUNS | 008486367 |
| Company Name | PRECISION DYNAMICS CORPORATION |
| Device Count | 25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10687225325087 [Primary] |
| GS1 | 80687225325086 [Unit of Use] |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2016-07-28 |
| 10687225488560 | Sample Pack - GANTRY GUARD™ CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM |
| 10687225325087 | GANTRY GUARD CT GANTRY COVER 1.6 MIL WITH ADHESIVE TABS PLASTIC 296 CM X 206 CM CLEAR |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GANTRY GUARD 87004774 5033567 Live/Registered |
Precision Dynamics Corporation 2016-04-18 |