HILZO Esophageal stents

GUDID 08800026632405

BCM Co., Ltd.

Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent Polymer-metal oesophageal stent

Primary Device ID	08800026632405
NIH Device Record Key	db6b028e-b63a-49af-9c3d-eeb67b51d484
Commercial Distribution Status	In Commercial Distribution
Brand Name	HILZO Esophageal stents
Version Model Number	EVP2008HUS2
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	08800026632405 [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