25ga Curved Laser Probe
Catalog Number: | VS0120.25 |
---|---|
Company Name: | VORTEX SURGICAL, LLC |
Device Combination Product: | N/A |
Device Commercial Dsitribution End Date: | N/A |
Device Commercial Dsitribution Status: | In Commercial Distribution |
Device Count: | 1 |
Device Description: | 25ga Curved Laser Probe |
Device hctp: | N/A |
Device kit: | N/A |
Device Publish Date: | 2020-01-29 |
Device Record Status: | Published |
Direct Market Exempt: | N/A |
Has Donation ID number? | N/A |
DUNS Number: | 80375891 |
Has Expiration Date? | true |
Is Labelled as NRL: | N/A |
Is Labelled As No NRL: | true |
Has Lot Batch Number: | true |
Has Manufacutring Date: | true |
MRI Safety Status: | Labeling does not contain MRI Safety Information |
Is OTC? | N/A |
Is Devic Premarket Exempt: | N/A |
Public Device Record Key: | adfaf8c9-d24d-4aaa-b75c-7b0aadb1f491 |
Public Version Date: | 2022-07-25 |
Public Version Number: | 4 |
Public Version Status: | Update |
Is Rx? | true |
Has Serial Number? | N/A |
Is Single Use: | true |
Version Model Number: | VS0120.25 |
Adress: | Phone:636-778-4350 Extension: Email: info@vortexsurgical.com |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Ophthalmic solid-state laser system
An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
VS01202518
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
true
false
Product Codes
Product Code
Product Code Name
HQB
Photocoagulator And Accessories
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A