| Primary Device ID | 06974880990437 |
| NIH Device Record Key | 136bae4b-327f-475f-a8e8-f8b5d5a06837 |
| 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 |
| 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 |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Atherectomy Cutter Diameter | 1.6 Millimeter |
| Atherectomy Cutter Diameter | 2 Millimeter |
| Atherectomy Cutter Diameter | 2.3 Millimeter |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974880990437 [Primary] |
| NWW | Hysteroscope Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
[06974880990437]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-09 |
| Device Publish Date | 2023-05-01 |
| 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 |