PINNACLE RSS403

GUDID 30389701007312

PINNACLE Introducer Sheath

TERUMO MEDICAL CORPORATION

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 30389701007312
• NIH Device Record Key: 4017c53e-c5ee-4513-ae16-e039b329528f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE
• Version Model Number: RSS403
• Catalog Number: RSS403
• Company DUNS: 131489882
• Company Name: TERUMO MEDICAL CORPORATION
• 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@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: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 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 *Do not store at extreme temperature and humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid direct sunlight.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389701007311 [Primary]
GS1	30389701007312 [Package]; Contains: 00389701007311; Package: Shelfbox [10 Units]; In Commercial Distribution
GS1	50389701007316 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• DYB: INTRODUCER, CATHETER

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: 2019-06-07
• Device Publish Date: 2016-09-24

On-Brand Devices [PINNACLE]

• 50389701009402: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009392: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009372: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009361: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009354: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009341: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009334: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009323: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009310: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009309: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009297: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009280: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009279: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009262: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009174: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009167: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009149: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009132: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 30389701009118: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701009105: PINNACLE R/O II Introducer Sheath with Radiopaque Marker
• 50389701008603: PINNACLE TIF Introducer Sheath
• 30389701008593: PINNACLE TIF Introducer Sheath
• 50389701008580: PINNACLE TIF Introducer Sheath
• 50389701008573: PINNACLE TIF Introducer Sheath
• 30389701008562: PINNACLE TIF Introducer Sheath
• 50389701008559: PINNACLE TIF Introducer Sheath
• 30389701008548: PINNACLE TIF Introducer Sheath
• 30389701008531: PINNACLE TIF Introducer Sheath
• 50389701008337: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 30389701008326: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 50389701008313: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 30389701008302: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 50389701008290: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 50389701008283: PINNACLE R/O II HiFlo Introducer Sheath with Radiopaque Marker
• 50389701007767: PINNACLE Introducer Sheath
• 50389701007750: PINNACLE Introducer Sheath
• 50389701007743: PINNACLE Introducer Sheath
• 30389701007732: PINNACLE Introducer Sheath
• 30389701007725: PINNACLE Introducer Sheath
• 30389701007718: PINNACLE Introducer Sheath
• 50389701007705: PINNACLE Introducer Sheath
• 50389701007699: PINNACLE Introducer Sheath
• 30389701007688: PINNACLE Introducer Sheath
• 50389701007675: PINNACLE Introducer Sheath
• 50389701007668: PINNACLE Introducer Sheath
• 30389701007657: PINNACLE Introducer Sheath
• 30389701007640: PINNACLE Introducer Sheath
• 50389701007637: PINNACLE Introducer Sheath
• 30389701007626: PINNACLE Introducer Sheath
• 50389701007613: PINNACLE R/O II Introducer Sheath with Radiopaque Marker