GoBack Crossing Catheter

GUDID 07290017837222

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

• Primary Device ID: 07290017837222
• NIH Device Record Key: 211baaff-3d98-49e7-9dbc-489a8fe39d71
• Commercial Distribution Discontinuation: 2022-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoBack Crossing Catheter
• Version Model Number: GB 603-US 014P 120L
• Company DUNS: 649244308
• Company Name: UPSTREAM PERIPHERAL TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017837222 [Primary]

FDA Product Code

• PDU: Catheter For Crossing Total Occlusions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

[07290017837222]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [GoBack Crossing Catheter]

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