HILZO Esophageal stents

GUDID 08809423560151

BCM Co., Ltd.

Polymer-metal oesophageal stent

• Primary Device ID: 08809423560151
• NIH Device Record Key: 6d290199-9762-4b0f-8688-1cc2bc9d9f22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HILZO Esophageal stents
• Version Model Number: EVP2012HCS2
• Company DUNS: 690134873
• Company Name: BCM Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08809423560151 [Primary]

FDA Product Code

• ESW: Prosthesis, Esophageal

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [HILZO Esophageal stents]

• 08809468543102: EVP2008HCS2
• 08809468543089: EVP2006HCS2
• 08809423560168: EVP2015HCS2
• 08809423560151: EVP2012HCS2
• 08809423560144: EVP2010HCS2
• 08800026632474: EVP2015HUS2
• 08800026632443: EVP2012HUS2
• 08800026632429: EVP2010HUS2
• 08800026632405: EVP2008HUS2
• 08800026632382: EVP2006HUS2