AccessGUDID - DEVICE: Mi-EXT Distal Access Catheter (B293MIEXT69250)

GUDID

Device Identifier (DI) Information

Brand Name: Mi-EXT Distal Access Catheter
Version or Model: Mi-EXT-6925
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MIVI NEUROVASCULAR

Primary DI Number: B293MIEXT69250
Issuing Agency: HIBCC
Commercial Distribution End Date: December 07, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 076836823 *Terms of Use

Device Description: The MIVI Mi-EXT™ Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.

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):	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?
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163233	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: Dry and Dark

Clinically Relevant Size

[?]

Size Type Text
Length: 142 Centimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: a520f75a-63a9-40fd-b11c-edafaf2a4e0b
Public Version Date: December 22, 2021
Public Version Number: 7
DI Record Publish Date: June 01, 2017