25ga Internal Delivery Device (IDD)
Catalog Number: | VS0250.25 |
---|---|
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 Internal Delivery Device for use in viscodissection |
Device hctp: | N/A |
Device kit: | N/A |
Device Publish Date: | 2020-01-23 |
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: | true |
Public Device Record Key: | aa545b31-368b-49ac-a463-27b052860c3f |
Public Version Date: | 2020-01-31 |
Public Version Number: | 1 |
Public Version Status: | New |
Is Rx? | N/A |
Has Serial Number? | N/A |
Is Single Use: | true |
Version Model Number: | VS0250.25 |
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
Vitrectomy fluid/gas handling handpiece/cannula
A sterile, hand-held, invasive, ophthalmic surgical instrument intended to handle fluids and gases during vitreoretinal surgery. It is used for controlling the extraction of fluids, the internal drainage of subretinal fluid, retinal fold manipulation [proliferative vitreoretinopathie (PVR), retinotomies, translocation], and simultaneous or sequential gas/fluid exchange [fluid-air, air-gas, fluid-gas, fluid-perfluorocarbon (PFC), PFC-gas]. It consists of a handle with a blunt or soft tip/cannula, that is inserted into the eye, and may include aspiration tubing or an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
VS0250251
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
true
false
Product Codes
Product Code
Product Code Name
HMX
Cannula, Ophthalmic
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A