AccessGUDID - DEVICE: APTUS Heli-FX® (00643169647626)

GUDID

Device Identifier (DI) Information

Brand Name: APTUS Heli-FX®
Version or Model: HG-16-62-28
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC VASCULAR, INC.

Primary DI Number: 00643169647626
Issuing Agency: GS1
Commercial Distribution End Date: December 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080009661 *Terms of Use

Device Description: GUIDE HG-16-62-28 AAA ENDOANCH 62CM MDT

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):	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 [?]
K140036	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: (10-40° C)(30-75% RH)
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 28 MM Tip Reach Length
Outer Diameter: 5.3 Millimeter
Device Size Text, specify: 62 CM Sheath Working Length
Device Size Text, specify: .89 MM Maximum Guide Wire Diameter

Device Record Status

Public Device Record Key: 470e8009-1b85-4cdb-805a-0a484d3c9384
Public Version Date: March 14, 2025
Public Version Number: 7
DI Record Publish Date: October 21, 2015