| Primary Device ID | 16974880993213 |
| NIH Device Record Key | 93ea5a6d-f92c-4b1a-98a8-1e492e505a4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hook grasper |
| Version Model Number | RSI-370-9-G |
| 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 | false |
| 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 | false |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com | |
| Phone | 6178344997 |
| frank.huang@sz-acuvu.com |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| 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 Temperature | Between -30 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974880993216 [Primary] |
| GS1 | 16974880993213 [Package] Contains: 06974880993216 Package: [1 Units] In Commercial Distribution |
| GS1 | 26974880993210 [Package] Contains: 06974880993216 Package: [5 Units] In Commercial Distribution |
| HTD | Forceps |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
[16974880993213]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-16 |
| Device Publish Date | 2025-05-08 |
| 06974880990611 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880990604 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880991410 | The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodi |
| 16974880993213 | The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodi |
| 16974880993169 | The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodi |