Glider PTCA BAlloon Catheter

GUDID M8744100A30081

TRIREME MEDICAL, LLC

Coronary angioplasty balloon catheter, basic

• Primary Device ID: M8744100A30081
• NIH Device Record Key: 46a17b22-4182-41ef-88f2-4771c77b5973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glider PTCA BAlloon Catheter
• Version Model Number: B
• Company DUNS: 623861577
• Company Name: TRIREME MEDICAL, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M8744100A30081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121681

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-02-13

On-Brand Devices [Glider PTCA BAlloon Catheter]

• M8744100A35201: B
• M8744100A35121: B
• M8744100A35081: B
• M8744100A35041: B
• M8744100A30201: B
• M8744100A30121: B
• M8744100A30081: B
• M8744100A30041: B
• M8744100A25201: B
• M8744100A25121: B
• M8744100A25081: B
• M8744100A25041: B
• M8744100A20201: A
• M8744100A20121: A
• M8744100A20081: A
• M8744100A20041: A
• M8744100A15201: A
• M8744100A15121: A
• M8744100A15081: A
• M8744100A15041: A