FDA UDI
In Commercial Distribution
🇺🇸 United States
ProFlex™
DI: 00816959020538
·
Model: Reusable 200 Laser Lithotripsy Fiber
·
INNOVAQUARTZ LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProFlex™
- Primary DI
- 00816959020538
- Version / Model
- Reusable 200 Laser Lithotripsy Fiber
- Catalog Number
- R-LLF200LT, R-LLF200TG, R-LLF200-OCS
- Company Name
- INNOVAQUARTZ LLC
- Labeler DUNS
- 079295103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 63ae4495-851b-4c0f-b5f0-c8a63cb6b343
Device Description
Maximum Power (J x PPS): 30W. Wavelengths Range: 500nm to 2200nm.
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
- 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
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
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 |
|---|---|---|---|---|
| 61474 | General/multiple surgical laser system beam guide, reusable | A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816959020538 | GS1 |
Customer Contacts
- Phone
- 1-844-776-3539
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142638 | 000 |