FDA UDI
In Commercial Distribution
🇺🇸 United States
LEONI™
DI: 00816901022351
·
Model: LFS-600-SF
·
Weinert Fiber Optics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LEONI™
- Primary DI
- 00816901022351
- Version / Model
- LFS-600-SF
- Catalog Number
- 098900
- Company Name
- Weinert Fiber Optics, Inc.
- Labeler DUNS
- 039281260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-28
- Public Version
- 2
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- 12de4970-835d-4962-a2df-62961e60a8a8
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
- 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 |
|---|---|---|---|---|
| 47785 | Urogenital surgical laser system beam guide, single-use | 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, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 01816901022350 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00816901022351 | GS1 | ||||
| Package | 02816901022359 | GS1 | 5 | In Commercial Distribution |