AccessGUDID - DEVICE: BeBack Crossing Catheter (04260279096456)

GUDID

Device Identifier (DI) Information

Brand Name: BeBack Crossing Catheter
Version or Model: 2.9 F, 80 cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GB-603-US-014P-80L
Company Name: Bentley InnoMed GmbH

Primary DI Number: 04260279096456
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331383450 *Terms of Use
Previous DI: 07290017837239

Device Description: The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm.

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?
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDU	Catheter For Crossing Total Occlusions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211802	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 dry, dark area away from heat and chemical fluids.

Clinically Relevant Size

[?]

Size Type Text
Introducer Sheath Compatibility: 2.9 French
Catheter Length: 80 Centimeter

Device Record Status

Public Device Record Key: f7de02d9-a4bc-4ebf-8479-03bc3a4deff6
Public Version Date: January 10, 2025
Public Version Number: 3
DI Record Publish Date: April 24, 2023