FDA UDI
In Commercial Distribution
🇺🇸 United States
LongPulse
DI: 07898961835037
·
Model: 18085
·
VYDENCE MEDICAL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LongPulse
- Primary DI
- 07898961835037
- Version / Model
- 18085
- Catalog Number
- 18085
- Company Name
- VYDENCE MEDICAL
- Labeler DUNS
- 904013281
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-27
- Public Version
- 1
- Public Version Date
- 2024-06-04
- Public Version Status
- New
- Public Device Record Key
- b2fa6749-b1ac-48bd-b794-f40af84799af
Device Description
LongPulse
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
- Yes
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45221 | Dermatological laser beam guiding handpiece | A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898961835037 | GS1 |
Customer Contacts
- Phone
- +551633065050
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171443 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 70 Degrees Celsius