FDA UDI
In Commercial Distribution
🇺🇸 United States
INFRARED AND BLUE LIGHT FILTER UNIT
DI: 04953170396113
·
Model: MAJ-2308
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INFRARED AND BLUE LIGHT FILTER UNIT
- Primary DI
- 04953170396113
- Version / Model
- MAJ-2308
- Catalog Number
- N5769940
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-25
- Public Version
- 2
- Public Version Date
- 2022-12-12
- Public Version Status
- Update
- Public Device Record Key
- 261b14c0-cd5e-4fc7-a162-3e9f50c829e3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZI | System, X-Ray, Angiographic | Radiology | 892.1600 | 2 |
| EPT | Microscope, Surgical | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64399 | Surgical microscope video camera filter switch | A switching component of a surgical microscope video camera intended to facilitate either the application of a single light wavelength filter or the changing from one filter to another. The filters are incorporated within the main microscope assembly and are typically infrared and/or blue. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04953170396113 | GS1 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]