Flexxus® Endoscopic Biliary Stent LXB10100

GUDID 00801741099304

Flexxus® Endoscopic Biliary Stent, 10 mm x 100 mm (190cm deployment system)

Angiomed GmbH & Co. Medizintechnik KG

Bare-metal biliary stent

• Primary Device ID: 00801741099304
• NIH Device Record Key: c037ddc9-cf59-407e-9f52-4d369c7e54d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexxus® Endoscopic Biliary Stent
• Version Model Number: LXB10100
• Catalog Number: LXB10100
• Company DUNS: 320047483
• Company Name: Angiomed GmbH & Co. Medizintechnik KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com
• Phone: +4972194450
• Email: ute.dreschner@crbard.com

Device Dimensions

• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741099304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031186

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-02

On-Brand Devices [Flexxus® Endoscopic Biliary Stent]

• 00801741099304: Flexxus® Endoscopic Biliary Stent, 10 mm x 100 mm (190cm deployment system)
• 00801741099298: Flexxus® Endoscopic Biliary Stent, 10 mm x 80 mm (190cm deployment system)
• 00801741099281: Flexxus® Endoscopic Biliary Stent, 10 mm x 60 mm (190cm deployment system)
• 00801741099274: Flexxus® Endoscopic Biliary Stent, 10 mm x 40 mm (190cm deployment system)
• 00801741099267: Flexxus® Endoscopic Biliary Stent, 8 mm x 100 mm (190cm deployment system)
• 00801741099250: Flexxus® Endoscopic Biliary Stent, 8 mm x 80 mm (190cm deployment system)
• 00801741099243: Flexxus® Endoscopic Biliary Stent, 8 mm x 60 mm (190cm deployment system)
• 00801741099236: Flexxus® Endoscopic Biliary Stent, 8 mm x 40 mm (190cm deployment system)