AccessGUDID - DEVICE: Sentry IVC Filter (05391529380069)

GUDID

Device Identifier (DI) Information

Brand Name: Sentry IVC Filter
Version or Model: 146155-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NM60-16-28
Company Name: NOVATE MEDICAL LIMITED

Primary DI Number: 05391529380069
Issuing Agency: GS1
Commercial Distribution End Date: October 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 896415242 *Terms of Use

Device Description: The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via percutaneous placement in the inferior vena cava in patients at transient risk of PE, in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated. • Failure of anticoagulant therapy in thromboembolic diseases. • Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41f8a47f-e5d1-4f41-a95a-f27d075a4e8b
Public Version Date: October 11, 2022
Public Version Number: 4
DI Record Publish Date: September 27, 2018