DC-OM-CCA, W, INT 145-018 6533-025

GUDID 00816349011702

LAKE REGION MEDICAL LIMITED

Peripheral vascular guidewire, manual

• Primary Device ID: 00816349011702
• NIH Device Record Key: a87d5980-fe21-4bc9-b702-7aaeb4a7311c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-OM-CCA, W, INT 145-018
• Version Model Number: LR1BG-057
• Catalog Number: 6533-025
• Company DUNS: 988555595
• Company Name: LAKE REGION 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: true
• 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

• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 145 Centimeter
• Outer Diameter: 0.018 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816349011702 [Primary]
GS1	10816349011709 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

Devices Manufactured by LAKE REGION MEDICAL LIMITED

• 08714729743156 - Starter™ Guidewire: 2021-12-22 "J" Curved Moveable Core Guidewire
• 08714729201281 - Starter™ Guidewire: 2021-12-22 Straight Fixed Core Guidewire
• 08714729742999 - Starter™ Guidewire: 2021-12-22 Straight Moveable Core Guidewire
• 08714729743040 - Starter™ Guidewire: 2021-12-22 "J" Curved Fixed Core Guidewire
• 08714729743125 - Starter™ Guidewire: 2021-12-22 "J" Curved Moveable Core Guidewire
• 08714729743200 - Starter™ Guidewire: 2021-12-22 Bentson Guidewire
• 08714729742951 - Starter™ Guidewire: 2021-12-22 Straight Fixed Core Guidewire
• 08714729326465 - Starter™ Guidewire: 2021-12-22 Straight Fixed Core Guidewire