FDA UDI
In Commercial Distribution
🇺🇸 United States
BIO delivery unit (Heine OMEGA)
DI: 04987669100110
·
Model: 17379-0000
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIO delivery unit (Heine OMEGA)
- Primary DI
- 04987669100110
- Version / Model
- 17379-0000
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e61f8433-b2d5-4273-9a4d-710b085c3e2a
Device Description
The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO.
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36150 | General/multiple surgical frequency-doubled solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987669100110 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]