FDA UDI
In Commercial Distribution
🇺🇸 United States
Attachable delivery unit (30SL)
DI: 04987669100226
·
Model: 17401-0000
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Attachable delivery unit (30SL)
- Primary DI
- 04987669100226
- Version / Model
- 17401-0000
- 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
- 0b3d81af-9dd3-4e24-8e98-cbfeaf3651ff
Device Description
This attachable slit lamp delivery unit allows you to form a photocoagulation system easily by mounting the delivery unit on your CARL ZEISS 30SL/M or NIDEK SL-1600 and connecting the delivery unit to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC-1000 main body. This unit is chiefly comprised of three units: Photocoagulation unit, protective filter unit (motorized) and illumination tower unit. With each unit attached, this laser system allows the operator to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the slit lamp.
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 | 04987669100226 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]