WEB Detachment Controller FGA00175

GUDID 10856956005289

WEB Detachment Controller

SEQUENT MEDICAL, INC.

Vascular implant detacher, single-use, sterile

• Primary Device ID: 10856956005289
• NIH Device Record Key: d9d013c6-b968-4bac-803e-31468d9ccbbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEB Detachment Controller
• Version Model Number: WDC-1
• Catalog Number: FGA00175
• Company DUNS: 796807340
• Company Name: SEQUENT MEDICAL, INC.
• 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: 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: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.com
• Phone: 949.830.9600
• Email: customerserviceus@sequentmedical.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
• 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
• 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	00856956005282 [Primary]
GS1	10856956005289 [Package]; Contains: 00856956005282; Package: Box of 5 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170032

FDA Product Code

• OPR: Intrasaccular Flow Disruption Device

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: 2019-08-15
• Device Publish Date: 2019-04-01

Devices Manufactured by SEQUENT MEDICAL, INC.

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• 00854111006037 - WEB Aneurysm Embolization System: 2019-08-15 WEB 21 SLS 7
• 00854111006044 - WEB Aneurysm Embolization System: 2019-08-15 WEB 21 SL 4x3
• 00854111006051 - WEB Aneurysm Embolization System: 2019-08-15 WEB 21 SL 4x4
• 00854111006068 - WEB Aneurysm Embolization System: 2019-08-15 WEB 21 SL 5x3
• 00854111006075 - WEB Aneurysm Embolization System: 2019-08-15 WEB 21 SL 5x4