AccessGUDID - DEVICE: Option Elite Retrievable Vena Cava Filter System (00886333217151)

GUDID

Device Identifier (DI) Information

Brand Name: Option Elite Retrievable Vena Cava Filter System
Version or Model: 352506070E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 352506070E
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333217151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Option Elite Retrievable Vena Cava Filter Suitable for Jugular or Femoral Delivery

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
44864	Vena cava filter, temporary/permanent	A vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTK	Filter, Intravascular, Cardiovascular

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep Dry and Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 70cm

Device Record Status

Public Device Record Key: c3e88230-99d8-4e1f-9fc7-de4d9496b54d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016