| Primary Device ID | 06974880991380 |
| NIH Device Record Key | a58046f2-4672-43ad-905d-2ac0e52d0e19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biopsy forceps |
| Version Model Number | RSI-370-5-C |
| 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 | 06974880991380 [Primary] |
| GS1 | 16974880991387 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 26974880991384 [Package] Package: [5 Units] In Commercial Distribution |
| HTD | Forceps |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
Moist Heat or Steam Sterilization
[06974880991380]
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 |
| 06974880990253 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880990246 | Hysteroscopic surgical instruments are used for the removal of uterine lesions; the surgical ins |
| 06974880991380 | The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for |
| 16974880993183 | The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for |
| 16974880993138 | The biopsy forceps are intended for use in hysteroscopy procedure to obtain tissue samples for |