AccessGUDID - DEVICE: Heli-FX™ Thoracic EndoAnchor™ System (00763000645168)

GUDID

Device Identifier (DI) Information

Brand Name: Heli-FX™ Thoracic EndoAnchor™ System
Version or Model: HG-18-90-32
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC VASCULAR, INC.

Primary DI Number: 00763000645168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080009661 *Terms of Use

Device Description: GUIDE HG-18-90-32 TAA ENDOANCH 32 EIFU

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":	No
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?
45612	Soft-tissue/mesh anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OTD	Endovascular suturing system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182957	000

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

Clinically Relevant Size

[?]

Size Type Text
Length: 32.0 Millimeter
Length: 90.0 Centimeter
Outer Diameter: 6.0 Millimeter

Device Record Status

Public Device Record Key: dfddfee1-58de-4be6-a252-fe30cbeb3641
Public Version Date: November 09, 2022
Public Version Number: 2
DI Record Publish Date: October 22, 2022