Ballast 088 Long Sheath N/A

GUDID 00840303712671

The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide catheter/long sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.

BALT USA LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00840303712671
• NIH Device Record Key: d4e13cd0-4638-4162-b808-5799853f274b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ballast 088 Long Sheath
• Version Model Number: BALLAST80SD
• Catalog Number: N/A
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Catheter Inner Diameter: 0.088 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840303712671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182918

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [Ballast 088 Long Sheath]

• 00818053022913: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00818053022906: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00818053022890: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00818053022883: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712817: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712800: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712794: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712787: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712688: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303712671: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303709497: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303709480: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303709473: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat
• 00840303709466: The Ballast 088 Long Sheath is a sterile, single use, single lumen, variable stiffness guide cat