AccessGUDID - DEVICE: 25ga Edge Advantage ILM Elevator (B384VS0300251)

GUDID

Device Identifier (DI) Information

Brand Name: 25ga Edge Advantage ILM Elevator
Version or Model: VS0300.25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VS0300.25
Company Name: Vortex Surgical, Inc.

Primary DI Number: B384VS0300251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080375891 *Terms of Use

Device Description: 25ga ILM Elevator

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?
47364	General-purpose ophthalmic hook, single-use	A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HNQ	Hook, 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
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: 647c7c42-d2e3-4e93-9b5e-243f56af1cb0
Public Version Date: November 21, 2022
Public Version Number: 3
DI Record Publish Date: November 30, 2016