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 |
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 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] |
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
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 |