AccessGUDID - DEVICE: 25ga Internal Delivery Device (IDD) (VS0250251)

GUDID

Device Identifier (DI) Information

Brand Name: 25ga Internal Delivery Device (IDD)
Version or Model: VS0250.25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VS0250.25
Company Name: Vortex Surgical, Inc.

Primary DI Number: VS0250251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080375891 *Terms of Use

Device Description: 25ga Internal Delivery Device for use in viscodissection

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47130	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa545b31-368b-49ac-a463-27b052860c3f
Public Version Date: November 21, 2022
Public Version Number: 2
DI Record Publish Date: January 23, 2020