AccessGUDID - DEVICE: Bendit2.7 Steerable Microcatheter (17290018072001)

GUDID

Device Identifier (DI) Information

Brand Name: Bendit2.7 Steerable Microcatheter
Version or Model: BDT01200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BEND IT TECHNOLOGIES LTD

Primary DI Number: 17290018072001
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 600476669 *Terms of Use

Device Description: The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
KRA	Catheter, Continuous Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200582	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: b1b6d21d-e948-46c0-9e97-d6217d549e5e
Public Version Date: September 01, 2020
Public Version Number: 1
DI Record Publish Date: August 24, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status
27290018072008	1	17290018072001	2030-12-31	In Commercial Distribution
37290018072005	3	27290018072008	2030-12-31	In Commercial Distribution
47290018072002	5	27290018072008	2030-12-31	In Commercial Distribution
57290018072009	10	27290018072008	2030-12-31	In Commercial Distribution