| Primary Device ID | 06974880991373 |
| NIH Device Record Key | 7a843e2d-b01d-4176-8d16-6371c35ad54d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single action scissors |
| Version Model Number | RSI-370-5-A |
| 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 |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| 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 Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974880991373 [Primary] |
| LRW | Scissors, General, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
Moist Heat or Steam Sterilization
[06974880991373]
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 |
| 26974880991421 - HTx Procedure Pack | 2024-07-08 The procedure pack is an accessory kit of the HTx disposable hysteroscope system, which contains an inflow tubing, a drainage fl |
| 06974880991373 - Single action scissors | 2024-03-29The single action scissors are intended for use in hysteroscopy procedures for cutting of soft tissue such as polyps from the uterine cavity. |
| 06974880991373 - Single action scissors | 2024-03-29 The single action scissors are intended for use in hysteroscopy procedures for cutting of soft tissue such as polyps from the ut |
| 06974880991380 - Biopsy forceps | 2024-03-29 The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the u |
| 06974880991397 - Serrated forceps | 2024-03-29 The serrated forceps are intended for use in hysteroscopy procedure to obtain tissue samples for examination of tissue from the |
| 06974880991403 - Alligator grasper | 2024-03-29 The alligator grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uter |
| 06974880991410 - Hook grasper | 2024-03-29 The hook grasper is intended to be used in hysteroscopy procedure for retrieval of foreign bodies and tissues from the uterine |
| 06974880991366 - Portable Image Processor | 2024-03-28 The HTx2000 Portable Image Processor is mainly used to process image signal captured from the disposable hysteroscope and presen |
| 26974880990684 - Y-type Irrigation Set with 3-way Stopcock | 2023-12-26 It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion. |