FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm
DI: 04049584024077
·
Model: 54412
·
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm
- Primary DI
- 04049584024077
- Version / Model
- 54412
- Company Name
- OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317138956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 2
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 0244777b-8e91-456f-a657-785d3db54f54
Device Description
BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOH | Spectacle, Operating (Loupe), Ophthalmic | Ophthalmic | 886.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64676 | Ophthalmic surgical microscope | An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04049584008275 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 04049584024077 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal