SeQure

GUDID 07290017268347

SeQure Microcatheter - 1.9 Fr., 130 cm, used with Small Beads.

ACCURATE MEDICAL THERAPEUTICS LTD

Vascular microcatheter

• Primary Device ID: 07290017268347
• NIH Device Record Key: a7858f96-d532-4bf5-9aca-cb3676e87c65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeQure
• Version Model Number: SQ19_SB_130
• Company DUNS: 532177871
• Company Name: ACCURATE MEDICAL THERAPEUTICS LTD
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017268347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202797

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2021-07-30
• Device Publish Date: 2021-07-22

On-Brand Devices [SeQure]

• 07290017268088: SeQure Microcatheter - 2.8 Fr., 150 cm, used with Large Beads
• 07290017268071: SeQure Microcatheter - 2.8 Fr., 130 cm, used with Large Beads
• 07290017268064: SeQure Microcatheter - 2.8 Fr., 105 cm, Used with Large Beads
• 07290017268057: SeQure Microcatheter - 2.7 Fr., 150 cm, used with Medium Beads
• 07290017268040: SeQure Microcatheter - 2.7 Fr., 130 cm, used with Medium Beads
• 07290017268033: SeQure Microcatheter - 2.7 Fr., 105 cm, used with Medium Beads
• 07290017268026: Sequre Microcatheter - 2.4 Fr., 150 cm, used with Medium Beads
• 07290017268019: Sequre Microcatheter - 2.4 Fr., 130 cm, used with Medium Beads
• 07290017268002: SeQure Microcatheter - 2.4 Fr, 105cm, used with Medium Beads
• 07290017268309: SeQure Microcatheter - 1.7 Fr., 105cm, used with Small Beads
• 07290017268408: SeQure Microcatheter - 3.0 Fr., 155 cm, used with Extra Large Beads.
• 07290017268392: SeQure Microcatheter - 3.0 Fr., 130 cm, used with Extra Large Beads.
• 07290017268385: SeQure Microcatheter - 3.0 Fr., 105 cm, used with Extra Large Beads.
• 07290017268378: SeQure Microcatheter - 2.7 Fr. XSB, 155 cm, used with Extra Small Beads
• 07290017268361: SeQure Microcatheter - 2.7 Fr. XSB, 130 cm, used with Extra Small Beads.
• 07290017268354: SeQure Microcatheter - 1.9 Fr., 155 cm, used with Small Beads.
• 07290017268347: SeQure Microcatheter - 1.9 Fr., 130 cm, used with Small Beads.
• 07290017268330: SeQure Microcatheter - 1.9 Fr., 105 cm, used with Small Beads.
• 07290017268323: SeQure Microcatheter - 1.7 Fr., 155 cm, used with Small Beads
• 07290017268316: SeQure Microcatheter - 1.7 Fr., 130 cm, used with Small Beads