GoBack Crossing Catheter

GUDID 07290017837109

The Upstream™ GoBack (GB) 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 Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.

UPSTREAM PERIPHERAL TECHNOLOGIES LTD

Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter
Primary Device ID07290017837109
NIH Device Record Key6b76af2c-bf3b-416a-89f4-d27326b25ff4
Commercial Distribution Discontinuation2022-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameGoBack Crossing Catheter
Version Model NumberGB 600-US 018P 120L
Company DUNS649244308
Company NameUPSTREAM PERIPHERAL TECHNOLOGIES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017837109 [Primary]

FDA Product Code

PDUCatheter For Crossing Total Occlusions

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


[07290017837109]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-27
Device Publish Date2022-10-19

On-Brand Devices [GoBack Crossing Catheter]

07290017837239The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular inter
07290017837222The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular inter
07290017837116The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular inter
07290017837109The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular inter

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