FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilized Endophoto Probe(25G/Coaxial)
DI: 04987669101322
·
Model: 11143-7500
·
NIDEK CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterilized Endophoto Probe(25G/Coaxial)
- Primary DI
- 04987669101322
- Version / Model
- 11143-7500
- Company Name
- NIDEK CO.,LTD.
- Labeler DUNS
- 690635461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-23
- Public Version
- 1
- Public Version Date
- 2018-05-24
- Public Version Status
- New
- Public Device Record Key
- ce766617-8d40-4452-85fb-484d143103a5
Device Description
It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory and is disposable. Sterilized endophoto probes are available in a variety of tip shapes and diameters.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61162 | Ophthalmic laser system beam guide | A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04987669100417 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 04987669101322 | GS1 |
Customer Contacts
- Phone
- 1-800-223-9044
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 25 | Gauge |