HYBRID Guidewire

GUDID 00818053022807

HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.

BALT USA LLC

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00818053022807
• NIH Device Record Key: ad91f2a1-eab5-40fe-b64a-7cca09d62ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYBRID Guidewire
• Version Model Number: HYBRID014D
• 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

Device Dimensions

• Device Size Text, specify: 0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818053022807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182337

FDA Product Code

• MOF: Guide, Wire, Catheter, Neurovasculature

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: 2019-01-01
• Device Publish Date: 2018-12-01

On-Brand Devices [HYBRID Guidewire]

• 00818053022852: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022814: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022807: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022791: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022784: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022777: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022760: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022753: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022746: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo
• 00818053022739: HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter fo