DEVICE: 25ga Edge Advantage ILM Elevator (B384VS0300251)

Device Identifier (DI) Information

25ga Edge Advantage ILM Elevator
VS0300.25
In Commercial Distribution
VS0300.25
VORTEX SURGICAL, LLC
B384VS0300251
HIBCC

1
080375891 *Terms of Use
25ga ILM Elevator
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HNQ Hook, Ophthalmic
CLOSE

FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Needle Gauge: 25 Gauge
CLOSE

Device Record Status

647c7c42-d2e3-4e93-9b5e-243f56af1cb0
March 29, 2018
2
November 30, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B384VS0300255 5 B384VS0300251 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6367784350
info@vortexsurgical.com
CLOSE