Drakon

GUDID 07290017268880

Drakon Microcatheter - 3.0 Fr., 155 cm

ACCURATE MEDICAL THERAPEUTICS LTD

Vascular microcatheter

• Primary Device ID: 07290017268880
• NIH Device Record Key: 1b7ac17c-4240-4984-993b-3be7b39e123b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drakon
• Version Model Number: DK30_155
• 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 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017268880 [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 [Drakon]

• 07290017268583: Drakon Microcatheter - 2.8 Fr., 150 cm
• 07290017268576: Drakon Microcatheter - 2.8 Fr., 130 cm
• 07290017268569: Drakon Microcatheter - 2.8 Fr., 105 cm
• 07290017268552: Drakon Microcatheter - 2.7 Fr., 150 cm
• 07290017268545: Drakon Microcatheter - 2.7 Fr., 130 cm
• 07290017268538: Drakon Microcatheter - 2.7 Fr., 105 cm
• 07290017268521: Drakon Microcatheter, 2.4 Fr., 150 cm
• 07290017268514: Drakon Microcatheter, 2.4 Fr., 130 cm
• 07290017268507: Drakon Microcatheter - 2.4 Fr., 105 cm
• 07290017268859: Drakon Microcatheter - 1.9 Fr., 155 cm
• 07290017268842: Drakon Microcatheter - 1.9 Fr., 130 cm
• 07290017268835: Drakon Microcatheter - 1.9 Fr., 105 cm
• 07290017268880: Drakon Microcatheter - 3.0 Fr., 155 cm
• 07290017268873: Drakon Microcatheter - 3.0 Fr., 130 cm
• 07290017268866: Drakon Microcatheter - 3.0 Fr., 105 cm
• 07290017268828: Drakon Microcatheter - 1.7 Fr., 155 cm.
• 07290017268811: Drakon Microcatheter - 1.7 Fr., 130 cm
• 07290017268804: Drakon Microcatheter - 1.7 Fr., 105 cm