DEVICE: 25ga Soft Tip Cannula (B384VS0200251)

Download: XML | JSON

Device Identifier (DI) Information

25ga Soft Tip Cannula
VS0200.25
VS0200.25
VORTEX SURGICAL, LLC
B384VS0200251
HIBCC
1
25ga Soft Tip Cannula
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Vitrectomy fluid/gas handling instrument A sterile, hand-held, manual, 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, that is inserted into the eye, and is equipped with tubing for aspiration and an integral backflush reservoir for retrograde flushing of incarcerated tissue during aspiration. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HMX Cannula, Ophthalmic
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 Status

In Commercial Distribution
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
B384VS0200255 5 B384VS0200251 In Commercial Distribution
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE