| Primary Device ID | 06974880991403 |
| NIH Device Record Key | 42af9da5-3f62-497c-af9c-19a64e9032b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alligator grasper |
| Version Model Number | RSI-370-5-E |
| Company DUNS | 705464292 |
| Company Name | Suzhou AcuVu medical technology Co., Ltd. |
| 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 | true |
| Single Use | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974880991403 [Primary] |
| GS1 | 16974880991400 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 26974880991407 [Package] Package: [5 Units] In Commercial Distribution |
| HTD | Forceps |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
[06974880991403]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-29 |
| Device Publish Date | 2024-03-21 |
| 06974880990437 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880990420 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880991403 | The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign |
| 16974880993206 | The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign |
| 16974880993152 | The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign |