ELM PTA Balloon Dilatation Catheter

GUDID 05391525781198

ELM Extension HP PTA 16mm x 40mm x 75cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525781198
• NIH Device Record Key: 2fd3e88b-c26e-4100-8311-5fe99dd24cf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELM PTA Balloon Dilatation Catheter
• Version Model Number: ELMEX1640L
• Company DUNS: 985021909
• Company Name: CREAGH MEDICAL LIMITED
• 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

Device Dimensions

• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525781198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143561

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2016-09-22

On-Brand Devices [ELM PTA Balloon Dilatation Catheter]

• 05391525781198: ELM Extension HP PTA 16mm x 40mm x 75cm
• 05391525781181: ELM Extension HP PTA 14mm x 40mm x 75cm
• 05391525781174: ELM Extension HP PTA 12mm x 40mm x 75cm