| Primary Device ID | D683PSS34201 |
| NIH Device Record Key | 138b3126-6ca1-4b48-a8fa-0d12cc4f9f90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pinnacle X-Ray Sensor Sheaths |
| Version Model Number | PSS3420C |
| Company DUNS | 145963778 |
| Company Name | METREX RESEARCH, LLC |
| Device Count | 100 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +18008411428 |
| customercare@kavokerrgroup.com | |
| Phone | +18008411428 |
| customercare@kavokerrgroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00615375004845 [Primary] |
| GS1 | 00615375007600 [Unit of Use] |
| HIBCC | D683PSS34201 [Secondary] |
| MMP | Cover, barrier, protective |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-15 |
| D683PSS34201 | Fits Kodak Size 2 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS34101 | Fits Kodak Size 1 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS34001 | Fits Kodak Size 0 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS33501 | Fits Schick CDR Elite Size 2 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS33401 | Fits Schick CDR Elite Size 1 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS33201 | Fits Schick CDR Size 2 CustomFitted for Your Sensor UltraSoft Material Soft Seams |
| D683PSS33101 | Fits Schick CDR Size 1 CustomFitted for Your Sensor UltraSoft Material Soft Seams |