Biliary Drainage Tube

GUDID 14953170046480

OLYMPUS MEDICAL SYSTEMS CORP.

Biliary drainage catheter Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: 14953170046480
• NIH Device Record Key: 7f92bbf8-d2b0-4d65-9d10-2c02e0a5c713
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biliary Drainage Tube
• Version Model Number: PBD-210-1015
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170046483 [Primary]
GS1	14953170046480 [Package]; Contains: 04953170046483; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933200

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Biliary Drainage Tube]

• 14953170047029: PBD-421-1015
• 14953170047012: PBD-421-1014
• 14953170047005: Biliary Drainage Tube
• 14953170046992: Biliary Drainage Tube
• 14953170046985: Biliary Drainage Tube
• 14953170046978: PBD-421-1010
• 14953170046961: Biliary Drainage Tube
• 14953170046954: PBD-421-1008
• 14953170046947: Biliary Drainage Tube
• 14953170046930: PBD-421-1006
• 14953170046923: Biliary Drainage Tube
• 14953170046916: Biliary Drainage Tube
• 14953170046879: PBD-211-1212
• 14953170046862: PBD-211-1209
• 14953170046855: PBD-211-1207
• 14953170046848: PBD-211-1205
• 14953170046831: PBD-211-1203
• 14953170046800: PBD-211-1015
• 14953170046794: PBD-211-1012
• 14953170046787: PBD-211-1009
• 14953170046770: PBD-211-1007
• 14953170046763: PBD-211-1005
• 14953170046756: PBD-211-1003
• 14953170046718: PBD-211-0815
• 14953170046701: PBD-211-0812
• 14953170046695: PBD-211-0809
• 14953170046688: PBD-211-0807
• 14953170046671: PBD-211-0805
• 14953170046664: PBD-211-0803
• 14953170046633: PBD-211-0715
• 14953170046626: PBD-211-0712
• 14953170046619: PBD-211-0709
• 14953170046602: PBD-211-0707
• 14953170046596: PBD-211-0705
• 14953170046589: PBD-211-0703
• 14953170046565: PBD-210-1215
• 14953170046558: PBD-210-1212
• 14953170046541: PBD-210-1209
• 14953170046534: PBD-210-1207
• 14953170046527: PBD-210-1205
• 14953170046510: PBD-210-1203
• 14953170046480: PBD-210-1015
• 14953170046473: PBD-210-1012
• 14953170046466: PBD-210-1009
• 14953170046459: PBD-210-1007
• 14953170046442: PBD-210-1005
• 14953170046435: PBD-210-1003
• 14953170046404: PBD-210-0815
• 14953170046398: PBD-210-0812
• 14953170046381: PBD-210-0809