ENROUTE 0.014" Guidewire

GUDID 00816349014857

BRIVANT LIMITED

Peripheral vascular guidewire, manual

• Primary Device ID: 00816349014857
• NIH Device Record Key: 7953ace9-6a33-4128-8c8d-9c44e8197f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENROUTE 0.014" Guidewire
• Version Model Number: 901047-01
• Company DUNS: 985303473
• Company Name: BRIVANT 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816349014857 [Primary]
GS1	10816349014854 [Package]; Package: Box [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: 2024-12-11
• Device Publish Date: 2024-12-03

Devices Manufactured by BRIVANT LIMITED

• 00816349014857 - ENROUTE 0.014" Guidewire: 2024-12-11
• 00816349014857 - ENROUTE 0.014" Guidewire: 2024-12-11
• 00860009941304 - Aximed Prime Soft Shapeable Tip Vascular Guidewire: 2023-07-05 Aximed Prime Soft Shapeable Tip Vascular Guidewire , 0.014", 180cm, Standard (901017- 01-AXI) - 00860009941304
• 00860009941311 - Aximed Prime Soft Shapeable Tip Vascular Guidewire: 2023-07-05 Aximed Prime Soft Shapeable Tip Vascular Guidewire, 0.018", 180cm, Standard (901017- 03-AXI) - 00860009941311
• 00860009941328 - Aximed Prime Soft Shapeable Tip Vascular Guidewire: 2023-07-05 Aximed Prime Soft Shapeable Tip Vascular Guidewire, 0.014", 200cm, Standard (901017-09-AXI) - 00860009941328
• 00816349014154 - Charter Guidewire, 0.014", 180cm, Standard: 2023-04-13 Charter Guidewire, 0.014", 180cm, Standard (45-281) - 00816349014154
• 00816349014161 - Charter Guidewire, 0.018", 140cm, Standard: 2023-04-13 Charter Guidewire, 0.018", 140cm, Standard (45-282) - 00816349014161
• 00816349014178 - Charter Guidewire, 0.018", 180cm, Standard: 2023-04-13 Charter Guidewire, 0.018", 180cm, Standard (45-283) - 00816349014178
• 00816349014185 - Charter Guidewire, 0.014", 180cm, Soft: 2023-04-13 Charter Guidewire, 0.014", 180cm, Soft (45-284) - 00816349014185