FDA UDI
In Commercial Distribution
🇺🇸 United States
BIO delivery unit (Keeler)
DI: 04987669100271
·
Model: 17120-0000
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIO delivery unit (Keeler)
- Primary DI
- 04987669100271
- Version / Model
- 17120-0000
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fd78b283-8a81-4897-b853-a4ffad4a26b4
Device Description
This unit is connected to the NIDEK GREEN LASER DIODE PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. (HEINE OMEGA 180 TYPE). The comprised photocoagulation system makes it possible to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O..
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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 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 | 04987669100271 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]