| Primary Device ID | 10850033976318 |
| NIH Device Record Key | ca5d8bce-6340-4ffc-b598-d1243c0a925f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HERizon Disposable Endoscopic Scissors |
| Version Model Number | JY-JD-17-350-B |
| Catalog Number | JY-JD-17-350-B |
| Company DUNS | 829616478 |
| Company Name | Minerva Surgical, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com | |
| Phone | 855-646-7874 |
| Customerservice@minervasurgical.com |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033976311 [Primary] |
| GS1 | 10850033976318 [Package] Contains: 00850033976311 Package: box [10 Units] In Commercial Distribution |
| GS1 | 20850033976315 [Package] Package: shipping box [9 Units] In Commercial Distribution |
| NWW | Hysteroscope Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-15 |
| Device Publish Date | 2024-10-07 |
| 00850033976250 - HERizon Medical Endoscope Image Processor | 2024-10-15 Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope. |
| 10850033976264 - HERizon Disposable Electronic Hysteroscope | 2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor |
| 10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy | 2024-10-15 Disposable Endoscopic Forceps - Biopsy |
| 10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper | 2024-10-15 Disposable Endoscopic Forceps - Foreign Body Grasper |
| 10850033976295 - HERizon Disposable Endoscopic Forceps – Alligator | 2024-10-15 Disposable Endoscopic Forceps – Alligator |
| 10850033976301 - HERizon Disposable Endoscopic Forceps - Inverted Tooth | 2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth |
| 10850033976318 - HERizon Disposable Endoscopic Scissors | 2024-10-15Disposable Endoscopic Scissors |
| 10850033976318 - HERizon Disposable Endoscopic Scissors | 2024-10-15 Disposable Endoscopic Scissors |
| 00850033976236 - INFINITY Fluid Management Accessory | 2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller. |