BeBack Crossing Catheter

Primary DI
04260279096487
Brand
BeBack Crossing Catheter
Company
Bentley InnoMed GmbH
Model
4 F, 120 cm
Catalog number
GB-600-US-018P-120L
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 oft he 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.
Published
2023-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211802000GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.2022-03-01PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017837109PreviousGS10
04260279096487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017837109072900178371097290017837109
04260279096487042602790964874260279096487

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length120Centimeter
Introducer Sheath Compatibilit4French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry, dark area away from heat and chemical fluids.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49747198499510info@bentley.global

Regulatory Flags#

DUNS number
331383450
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260279096456BeBack Crossing Catheter2.9 F, 80 cmGB-603-US-014P-80L2023-04-24
04260279096463BeBack Crossing Catheter2.9 F, 120 cmGB-603-US-014P-120L2023-04-24
04260279096470BeBack Crossing Catheter4 F, 80 cmGB-600-US-018P-80L2023-04-24

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