AccessGUDID - DEVICE: VALIANT® Captivia (00613994802927)

GUDID

Device Identifier (DI) Information

Brand Name: VALIANT® Captivia
Version or Model: VAMC4642C150TU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994802927
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: STENT GRAFT VAMC4642C150TU VALCAP TAPER

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?
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	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: Store at room temperature in a dark, dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Stent Graft Distal Diameter 42 MM
Device Size Text, specify: Stent Graft Proximal Diameter 46 MM
Device Size Text, specify: Stent Graft Covered Length 155 MM

Device Record Status

Public Device Record Key: 113e33c1-408d-43a8-bcb2-78ff0543e686
Public Version Date: December 11, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2014