AccessGUDID - DEVICE: Control 10T Mechanical Thrombectomy System Tubing (B090MT101000)

GUDID

Device Identifier (DI) Information

Brand Name: Control 10T Mechanical Thrombectomy System Tubing
Version or Model: MT10-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT10-100
Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.

Primary DI Number: B090MT101000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017535668 *Terms of Use

Device Description: The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”

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?
65026	Thrombectomy tubing set, non-electronic	A collection of noninvasive tubing and associated non-powered components (typically connectors, clamps and spikes) designed to conduct fluids from a container (e.g., bag) to a thrombectomy catheter (not included) to assist with the intravascular disruption and removal of clotted blood (i.e., a thrombus or thromboembolus); it does not include invasive devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYY	Tube, Aspirating, Flexible, Connecting

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aabcaaff-37fb-43a7-bf1e-c21bef5c41e8
Public Version Date: November 01, 2022
Public Version Number: 1
DI Record Publish Date: October 24, 2022