FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDIVISION
DI: 00851328007017
·
Model: MVA2701
·
MEDIVISION, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDIVISION
- Primary DI
- 00851328007017
- Version / Model
- MVA2701
- Catalog Number
- MVA2701
- 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
- 3
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- fc8797a8-9636-41e4-84d6-0d1ecd2f543d
Device Description
ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder, wrist (carpal ligament release), temporal-mandibular joint, ankle, elbow, and plantar fascia release. SINUSCOPE Intended use of MediVision Sinuscope is to allow direct visualization (through the Sinuscope or the video monitor) of the nasal cavity.
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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37180 | Rigid optical sinoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device. | No | Active |
| 34856 | Rigid optical arthroscope, reusable | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851328007017 | GS1 |