FDA UDI
In Commercial Distribution
🇺🇸 United States
Attachable delivery unit (30SL)
DI: 04987669100127
·
Model: 17461-0000
·
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
- 04987669100127
- Version / Model
- 17461-0000
- 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
- a1ea6c79-b796-4c96-a190-4d2a0a4c6f26
Device Description
This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body, to comprise the photocoagulation system and to treat affected areas using the slit lamp, Carl Zeiss Meditec 30 SL/M. This delivery unit is mainly comprised of the delivery unit, protective filter unit, and the split illumination mirror unit. This photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. This delivery unit can be attached only to the Carl Zeiss Meditec 30 SL/M.
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 | 04987669100127 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]