| Primary Device ID | 66925776123479 |
| NIH Device Record Key | 3f3fb16c-b44b-4f78-9f9c-718e1fc238f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use |
| Version Model Number | R45W |
| Catalog Number | R45W |
| Company DUNS | 421348845 |
| Company Name | Ezisurg Medical Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06925776123477 [Primary] |
| GS1 | 66925776123479 [Package] Contains: 06925776123477 Package: color box [6 Units] In Commercial Distribution |
| GS1 | 76925776123476 [Package] Package: traveling case [3 Units] In Commercial Distribution |
| GDW | Staple, Implantable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-15 |
| Device Publish Date | 2025-01-07 |
| 66925776123646 | Loading Units, 60±2mm Long, 4.1±0.2mm height, green |
| 66925776123639 | Loading Units, 60±2mm Long, 3.8±0.2mm height, gold |
| 66925776123622 | Loading Units, 60±2mm Long, 3.5±0.2mm height, blue |
| 66925776123615 | Loading Units, 60±2mm Long, 2.5±0.2mm height, white |
| 66925776123608 | Loading Units, 45±2mm Long, 4.1±0.2mm height, green |
| 66925776123592 | Loading Units, 45±2mm Long, 3.8±0.2mm height, gold |
| 66925776123585 | Loading Units, 45±2mm Long, 2.5±0.2mm height, white |
| 66925776123578 | Loading Units, 45±2mm Long, 2.5±0.2mm height, white |
| 66925776123561 | Loading Units, 30±2mm Long, 3.5±0.2mm height, blue |
| 66925776123554 | Loading Units, 30±2mm Long, 2.5±0.2mm height, white |
| 66925776123547 | Loading Units, 60±2mm Long, 4.1±0.2mm height, green |
| 66925776123530 | Loading Units, 60±2mm Long,3.8±0.2mm height, gold |
| 66925776123523 | Loading Units, 60±2mm Long, 3.5±0.2mm height, blue |
| 66925776123516 | Loading Units, 60±2mm Long, 2.5±0.2mm height, white |
| 66925776123509 | Loading Units, 45±2mm Long, 4.1±0.2mm height, green |
| 66925776123493 | Loading Units, 45±2mm Long, 3.8±0.2mm height, gold |
| 66925776123486 | Loading Units, 45±2mm Long, 3.5±0.2mm height, blue |
| 66925776123479 | Loading Units, 45±2mm Long, 2.5±0.2mm height, white |
| 66925776123462 | Loading Units, 30±2mm Long, 3.5±0.2mm height, blue |
| 66925776123455 | Loading Units, 30±2mm Long, 2.5±0.2mm height, white |
| 16925776123443 | Linear Cutting Stapler, 250±25mm Long |
| 16925776123436 | Linear Cutting Stapler, 160±16mm Long |
| 16925776123429 | Linear Cutting Stapler, 70±7mm Long |