ELM HP PTA

GUDID 05391518031446

ELM HP PTA 6mm x 20mm x 40cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391518031446
• NIH Device Record Key: 76724388-f457-4204-a9a0-57880dccda08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELM HP PTA
• Version Model Number: ELM620S
• 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: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391518031446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102645

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 HP PTA]

• 05391518031798: ELM HP PTA 12mm x 40mm x 75cm
• 05391518031781: ELM HP PTA 10mm x 40mm x 75cm
• 05391518031774: ELM HP PTA 9mm x 40mm x 75cm
• 05391518031767: ELM HP PTA 8mm x 80mm x 75cm
• 05391518031750: ELM HP PTA 8mm x 60mm x 75cm
• 05391518031743: ELM HP PTA 8mm x 40mm x 75cm
• 05391518031736: ELM HP PTA 8mm x 20mm x 75cm
• 05391518031729: ELM HP PTA 7mm x 100mm x 75cm
• 05391518031712: ELM HP PTA 7mm x 60mm x 75cm
• 05391518031705: ELM HP PTA 7mm x 40mm x 75cm
• 05391518031699: ELM HP PTA 7mm x 20mm x 75cm
• 05391518031682: ELM HP PTA 6mm x 100mm x 75cm
• 05391518031675: ELM HP PTA 6mm x 60mm x 75cm
• 05391518031668: ELM HP PTA 6mm x 40mm x 75cm
• 05391518031651: ELM HP PTA 6mm x 20mm x 75cm
• 05391518031644: ELM HP PTA 5mm x 60mm x 75cm
• 05391518031637: ELM HP PTA 5mm x 40mm x 75cm
• 05391518031620: ELM HP PTA 5mm x 20mm x 75cm
• 05391518031613: ELM HP PTA 4mm x 40mm x 75cm
• 05391518031606: ELM HP PTA 4mm x 20mm x 75cm
• 05391518031590: ELM HP PTA 3mm x 40mm x 75cm
• 05391518031583: ELM HP PTA 12mm x 40mm x 40cm
• 05391518031576: ELM HP PTA 10mm x 40mm x 40cm
• 05391518031569: ELM HP PTA 9mm x 40mm x 40cm
• 05391518031552: ELM HP PTA 8mm x 80mm x 40cm
• 05391518031545: ELM HP PTA 8mm x 60mm x 40cm
• 05391518031538: ELM HP PTA 8mm x 40mm x 40cm
• 05391518031521: ELM HP PTA 8mm x 20mm x 40cm
• 05391518031514: ELM HP PTA 7mm x 100mm x 40cm
• 05391518031507: ELM HP PTA 7mm x 60mm x 40cm
• 05391518031491: ELM HP PTA 7mm x 40mm x 40cm
• 05391518031484: ELM HP PTA 7mm x 20mm x 40cm
• 05391518031477: ELM HP PTA 6mm x 100mm x 40cm
• 05391518031460: ELM HP PTA 6mm x 60mm x 40cm
• 05391518031453: ELM HP PTA 6mm x 40mm x 40cm
• 05391518031446: ELM HP PTA 6mm x 20mm x 40cm
• 05391518031439: ELM HP PTA 5mm x 60mm x 40cm
• 05391518031422: ELM HP PTA 5mm x 40mm x 40cm
• 05391518031415: ELM HP PTA 5mm x 20mm x 40cm
• 05391518031408: ELM HP PTA 4mm x 40mm x 40cm
• 05391518031392: ELM HP PTA 4mm x 20mm x 40cm
• 05391518031385: ELM HP PTA 3mm x 40mm x 40cm