AccessGUDID - DEVICE: Bendit®21 Microcatheter (17290018072049)

GUDID

Device Identifier (DI) Information

Brand Name: Bendit®21 Microcatheter
Version or Model: BDT21157U2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BEND IT TECHNOLOGIES LTD

Primary DI Number: 17290018072049
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 600476669 *Terms of Use

Device Description: The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

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?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJP	Catheter, Percutaneous, Neurovasculature
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203842	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 000629eb-7efb-4412-af02-11bc5fdddc77
Public Version Date: June 17, 2022
Public Version Number: 1
DI Record Publish Date: June 09, 2022