| Primary Device ID | 00369771002225 | 
| NIH Device Record Key | b6864e17-7a63-4995-8637-4ac837863223 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Sterile Drape | 
| Version Model Number | 13-055 | 
| Company DUNS | 361663839 | 
| Company Name | GERI-GENTLE CORPORATION | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00369771002225 [Primary] | 
| GS1 | 10369771002222 [Package] Package: Inner [50 Units] In Commercial Distribution  | 
| PUI | Drape, Surgical, Exempt | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-07-11 | 
| Device Publish Date | 2022-07-01 | 
| 00369771003659 - Sharps Collector 5QT | 2023-11-09 Sharps Collector 5QT | 
| 00369771003390 - Pen Needle | 2023-09-11 Safety Pen Needle 30G | 
| 00369771003437 - Prefilled Syrings | 2023-09-11 10ML PREFILLED SYRINGE | 
| 00369771003161 - Oxygen Concentrator | 2023-08-09 Oxygen Concentrator | 
| 20369771000782 - Lancets Safety | 2023-08-09 Lancets Safety | 
| 00369771003123 - SYRINGE RETRACT U100 1cc 29x.5 | 2023-07-10 SYRINGE RETRACT U100 1cc 29x.5 | 
| 20369771000898 - Syringes Safety | 2023-02-22 SYR U100 1cc 29x.5 | 
| 20369771000904 - Syringes Safety | 2023-02-22 SYR U100 .5cc 29x.5 |