ULTRA Detach

GUDID 00818053029639

The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separates the coils from the pusher system.

BALT USA LLC

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• Primary Device ID: 00818053029639
• NIH Device Record Key: 1c67e385-1c02-4c19-994a-974eabeccec6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA Detach
• Version Model Number: ULTRA
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818053029639 [Primary]

FDA Product Code

• HCG: Device, Neurovascular Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2022-12-09

On-Brand Devices [ULTRA Detach]

• 00818053024351: The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separat
• 00818053029639: The ULTRA Detachment Controller is used in conjunction with the Prestige Coil System and separat