AccessGUDID - DEVICE: Valiant Navion™ (00763000260897)

GUDID

Device Identifier (DI) Information

Brand Name: Valiant Navion™
Version or Model: VNMC4040C175TU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000260897
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STENT GRAFT VNMC4040C175TU VAL NAV CS

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?
48060	Descending thoracic aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100040	036
P100040	041

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: Store the system at room temperature in a dark, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Stent Graft Proximal Diameter 40 MM
Device Size Text, specify: Stent Graft Length (Covered) 175 MM
Device Size Text, specify: Stent Graft Distal Diameter 40 MM

Device Record Status

Public Device Record Key: ff968779-db53-4f1a-a3cc-87a3426203fb
Public Version Date: December 11, 2024
Public Version Number: 5
DI Record Publish Date: April 26, 2020