WEB Aneurysm Embolization System FGA25050-030

GUDID 00854111006068

WEB 21 SL 5x3

SEQUENT MEDICAL, INC.

Neurovascular embolization coil

• Primary Device ID: 00854111006068
• NIH Device Record Key: e4981c2c-cd00-4830-ab9d-ca90f019f59b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEB Aneurysm Embolization System
• Version Model Number: W4-5-3
• Catalog Number: FGA25050-030
• Company DUNS: 796807340
• Company Name: SEQUENT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854111006068 [Primary]

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

On-Brand Devices [WEB Aneurysm Embolization System]

• 00856956005985: WEB 27 SL 9x4
• 00856956005978: WEB 27 SL 8x3
• 00856956005961: WEB 27 SL 11x9
• 00856956005954: WEB 27 SL 11x8
• 00856956005947: WEB 27 SL 11x7
• 00856956005930: WEB 27 SL 11x6
• 00856956005923: WEB 27 SL 10x8
• 00856956005916: WEB 27 SL 10x7
• 00856956005909: WEB 27 SL 10x6
• 00856956005893: WEB 27 SL 10x5
• 00856956005886: WEB 27 SL 9x8
• 00856956005879: WEB 27 SL 9x7
• 00856956005862: WEB 27 SL 9x6
• 00856956005855: WEB 27 SL 9x5
• 00856956005848: WEB 27 SL 8x7
• 00856956005831: WEB 27 SL 8x6
• 00856956005824: WEB 27 SL 8x5
• 00856956005817: WEB 27 SL 8x4
• 00856956005572: WEB 27 SLS 11
• 00856956005565: WEB 27 SLS 10
• 00856956005558: WEB 27 SLS 9
• 00856956005541: WEB 27 SLS 8
• 00854111006167: WEB 21 SL 7x6
• 00854111006150: WEB 21 SL 7x5
• 00854111006143: WEB 21 SL 7x4
• 00854111006136: WEB 21 SL 7x3
• 00854111006129: WEB 21 SL 6x6
• 00854111006112: WEB 21 SL 6x5
• 00854111006105: WEB 21 SL 6x4
• 00854111006099: WEB 21 SL 6x3
• 00854111006082: WEB 21 SL 5x5
• 00854111006075: WEB 21 SL 5x4
• 00854111006068: WEB 21 SL 5x3
• 00854111006051: WEB 21 SL 4x4
• 00854111006044: WEB 21 SL 4x3
• 00854111006037: WEB 21 SLS 7
• 00854111006020: WEB 21 SLS 6
• 00854111006013: WEB 21 SLS 5
• 00854111006006: WEB 21 SLS 4