Mediblu
- Primary DI
- B632MDB01039
- Brand
- Mediblu
- Company
- Medisono, LLC
- Model
- VIDEO COLPOSCOPE DVC200+
- Device description
- Main Unit
- Published
- 2022-05-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HEX | Colposcope (And Colpomicroscope) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HEX | Colposcope (And Colpomicroscope) | Obstetrics/Gynecology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B632MDB01039 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Colposcope | An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing. |
Regulatory Flags
- DUNS number
- 079686615
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| B369MUS05252 | MEDISONO | PHASED ARRAY PROBE MODEL 7P-B FOR MEDISONO MS12 | | 2024-01-24 |
| B369MUS05253 | MEDISONO | PENCIL PROBE MODEL PB-CWD 2.0 FOR MEDISONO MS12 | | 2024-01-24 |
| B369MES01001 | MEDISONO | Medisono END-VYS HD350 System | MES01001 | 2023-11-17 |
| B369MES01002 | MEDISONO | Medisono END-VYS HD500 System | MES01002 | 2023-11-17 |
| B369MES01003 | MEDISONO | Medisono END-VYS HD550 System | MES01003 | 2023-11-17 |
| B369MES01004 | MEDISONO | Medisono END-VYS X-2200Pro System | MES01004 | 2023-11-17 |
| B369MES01005 | MEDISONO | Medisono END-VYS HDL-35E Light Source | MES01005 | 2023-11-17 |
| B369MES01006 | MEDISONO | Medisono END-VYS VLS-50D Light Source | MES01006 | 2023-11-17 |
| B369MES01007 | MEDISONO | Medisono END-VYS VLS-55T Light Source | MES01007 | 2023-11-17 |
| B369MES01008 | MEDISONO | Medisono END-VYS VLS-55Q Light Source | MES01008 | 2023-11-17 |
| B369MES01009 | MEDISONO | Medisono END-VYS VLS-50T Light Source | MES01009 | 2023-11-17 |
| B369MES01010 | MEDISONO | Medisono END-VYS VLS-50D Light Source | MES01010 | 2023-11-17 |
| B369MES01011 | MEDISONO | Medisono END-VYS EG-430 Gastroscope | MES01011 | 2023-11-17 |
| B369MES01012 | MEDISONO | Medisono END-VYS EG-430L Gastroscope | MES01012 | 2023-11-17 |
| B369MES01013 | MEDISONO | Medisono END-VYS EG-500 Gastroscope | MES01013 | 2023-11-17 |
| B369MES01014 | MEDISONO | Medisono END-VYS EG-500L Gastroscope | MES01014 | 2023-11-17 |
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