PRIORITYONE UG1602

GUDID 54543334177259

PRIORITYONE Aspiration Catheter

TERUMO CLINICAL SUPPLY CO., LTD.

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• Primary Device ID: 54543334177259
• NIH Device Record Key: 6e94e7ab-b528-4d20-a2c9-41818327dd38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIORITYONE
• Version Model Number: 30-6100
• Catalog Number: UG1602
• Company DUNS: 691034748
• Company Name: TERUMO CLINICAL SUPPLY CO., 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

Customer Support Contacts

• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedica
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 140 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04543334177254 [Primary]
GS1	14543334177251 [Package]; Contains: 04543334177254; Package: Unit Box [1 Units]; In Commercial Distribution
GS1	54543334177259 [Package]; Contains: 04543334177254; Package: Carton [5 Units]; In Commercial Distribution
GS1	74543334177253 [Package]; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112382

FDA Product Code

• DXE: Catheter, Embolectomy

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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [PRIORITYONE]

• 74543334177260: PRIORITYONE Aspiration Catheter
• 54543334177259: PRIORITYONE Aspiration Catheter