FDA UDI
In Commercial Distribution
🇺🇸 United States
Mielscope
DI: 04547497771113
·
Model: Mielscope (Floor Stand with Casters)
·
YOSHIDA DENTAL MFG. CO., LTD., THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mielscope
- Primary DI
- 04547497771113
- Version / Model
- Mielscope (Floor Stand with Casters)
- Company Name
- YOSHIDA DENTAL MFG. CO., LTD., THE
- Labeler DUNS
- 690676978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-28
- Public Version
- 1
- Public Version Date
- 2023-12-06
- Public Version Status
- New
- Public Device Record Key
- ac70ee51-03eb-4759-85bc-5433be4559af
Device Description
Surgical Microscope (Floor Stand with Casters)
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
- Yes
- 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 |
|---|---|---|---|---|
| EPT | Microscope, Surgical | General, Plastic Surgery | 878.4700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62439 | Dental surgical microscope | A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547497771113 | GS1 |
Customer Contacts
- Phone
- +81336312165
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- .8 – 1.06 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .8 – 1.06 KiloPascal