Tryton Side Branch Stent T5-2535-191-US

GUDID 00894588002149

TRYTON MEDICAL, INC.

Bare-metal coronary artery stent

• Primary Device ID: 00894588002149
• NIH Device Record Key: 927cfd1e-7474-45a5-b0db-9fc45b9a9c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tryton Side Branch Stent
• Version Model Number: T5-2535-191-US
• Catalog Number: T5-2535-191-US
• Company DUNS: 828557293
• Company Name: TRYTON MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894588002149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150039

FDA Product Code

• MAF: Stent, Coronary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-06
• Device Publish Date: 2017-03-02

On-Brand Devices [Tryton Side Branch Stent]

• 00894588002187: T5-3035-151-US
• 00894588002170: T5-3540-151-US
• 00894588002163: T5-3035-181-US
• 00894588002156: T5-3540-181-US
• 00894588002149: T5-2535-191-US
• 00894588002132: T5-2530-191-US
• 00894588002125: T5-2525-191-US