Drakon

GUDID 07290017268514

Drakon Microcatheter, 2.4 Fr., 130 cm

ACCURATE MEDICAL THERAPEUTICS LTD

Vascular microcatheter

• Primary Device ID: 07290017268514
• NIH Device Record Key: e3fc44b4-783d-42a0-8cd9-cee432d2729e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drakon
• Version Model Number: DK24_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: false
• 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.
• 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	07290017268514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173430

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-03-21
• Device Publish Date: 2018-08-10

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