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

Vascular implant detacher, electronic, single-use

• 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