R2P NAVICROSS SC-R35STR200

GUDID 50389701012891

R2P NAVICROSS

TERUMO MEDICAL CORPORATION

Vascular guide-catheter, single-use

• Primary Device ID: 50389701012891
• NIH Device Record Key: 1576d160-8f9c-49f1-8692-e9a6b40a5a35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R2P NAVICROSS
• Version Model Number: SC-R35STR200
• Catalog Number: SC-R35STR200
• Company DUNS: 131489882
• Company Name: TERUMO MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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@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
• 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
• 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
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter
• Length: 200 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight. Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389701012896 [Primary]
GS1	50389701012891 [Package]; Contains: 00389701012896; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231044

FDA Product Code

• DQY: Catheter, percutaneous

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: 2024-01-19
• Device Publish Date: 2024-01-11

On-Brand Devices [R2P NAVICROSS]

• 50389701012907: R2P NAVICROSS
• 50389701012891: R2P NAVICROSS