FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDIVISION
DI: 00851328007178
·
Model: MV2900
·
MEDIVISION, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDIVISION
- Primary DI
- 00851328007178
- Version / Model
- MV2900
- Catalog Number
- MV2900
- Company Name
- MEDIVISION, INC.
- Labeler DUNS
- 942192550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-14
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 036c0d5a-3dd4-4761-8708-150f514f2ed1
Device Description
CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17145 | Rigid optical cystoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. It is used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, to remove tissue samples/stones/small tumours from the bladder, and for removal of the prostate. This is a reusable device. | No | Active |
| 36628 | Rigid optical hysteroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851328007178 | GS1 |