AccessGUDID - DEVICE: APTUS Heli-FX® (00643169647565)

GUDID

Device Identifier (DI) Information

Brand Name: APTUS Heli-FX®
Version or Model: HG-18-90-42
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC VASCULAR, INC.

Primary DI Number: 00643169647565
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080009661 *Terms of Use

Device Description: GUIDE HG-18-90-42 TAA ENDOANCH 90CM 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: 90 CM Sheath Working Length
Outer Diameter: 6.0 Millimeter
Device Size Text, specify: .89 MM Maximum Guide Wire Diameter
Device Size Text, specify: 42 MM Tip Reach Length

Device Record Status

Public Device Record Key: 8203f68b-759f-4a24-8f11-9abdc7a3bdee
Public Version Date: November 09, 2022
Public Version Number: 6
DI Record Publish Date: October 21, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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