FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuLight®
DI: 00816901023945
·
Model: WFR-600-SB
·
Weinert Fiber Optics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- NeuLight®
- Primary DI
- 00816901023945
- Version / Model
- WFR-600-SB
- Catalog Number
- 095633
- Company Name
- Weinert Fiber Optics, Inc.
- Labeler DUNS
- 039281260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-31
- Public Version
- 1
- Public Version Date
- 2023-08-08
- Public Version Status
- New
- Public Device Record Key
- cf7eae48-7fc3-4f8e-a937-c8dd07f1dd77
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 61470 | Urogenital surgical laser system beam guide, reusable | A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications [e.g., to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas), to heat/ablate mucosal tissue to treat vaginal laxity]. It is designed to direct laser light from a laser generator to the surgical site and may be available in a variety of configurations/technologies (using, e.g., fibreoptic materials, specialized mirrors). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 02816901023943 | GS1 | 2 | In Commercial Distribution | ||
| Package | 01816901023944 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00816901023945 | GS1 |