Single Use Biliary Drainage Stent V N4531931

GUDID 14953170460637

OLYMPUS MEDICAL SYSTEMS CORP.

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 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: 14953170460637
• NIH Device Record Key: 1869e8b8-bae7-4d76-821b-958d0f428867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Biliary Drainage Stent V
• Version Model Number: PBD-1032-1007
• Catalog Number: N4531931
• 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
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• Phone: +1(800)401-1086
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• 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	04953170460630 [Primary]
GS1	14953170460637 [Package]; Contains: 04953170460630; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103478

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [Single Use Biliary Drainage Stent V]

• 14953170347372: PBD-1033-0715
• 14953170347365: PBD-1033-0712
• 14953170347358: PBD-1033-0710
• 14953170347341: PBD-1033-0709
• 14953170347334: PBD-1033-0708
• 14953170347327: PBD-1033-0707
• 14953170347310: PBD-1033-0706
• 14953170347303: PBD-1033-0705
• 14953170347297: PBD-1033-0704
• 14953170347280: PBD-1033-0703
• 14953170347273: PBD-1032-1218
• 14953170347266: PBD-1032-1217
• 14953170347259: PBD-1032-1216
• 14953170347242: PBD-1032-1215
• 14953170347235: PBD-1032-1214
• 14953170347228: PBD-1032-1213
• 14953170347211: PBD-1032-1212
• 14953170347204: PBD-1032-1211
• 14953170347198: PBD-1032-1210
• 14953170347181: PBD-1032-1209
• 14953170347174: PBD-1032-1208
• 14953170347167: PBD-1032-1207
• 14953170347150: PBD-1032-1206
• 14953170347143: PBD-1032-1205
• 14953170347136: PBD-1032-1018
• 14953170347129: PBD-1032-1017
• 14953170347112: PBD-1032-1016
• 14953170347105: PBD-1032-1015
• 14953170347099: PBD-1032-1014
• 14953170347082: PBD-1032-1013
• 14953170347075: PBD-1032-1012
• 14953170347068: PBD-1032-1011
• 14953170347051: PBD-1032-1010
• 14953170347044: PBD-1032-1009
• 14953170347037: PBD-1032-1008
• 14953170347020: PBD-1032-1007
• 14953170347013: PBD-1032-1006
• 14953170347006: PBD-1032-1005
• 14953170346993: PBD-1032-0818
• 14953170346986: PBD-1032-0817
• 14953170346979: PBD-1032-0816
• 14953170346962: PBD-1032-0815
• 14953170346955: PBD-1032-0814
• 14953170346948: PBD-1032-0813
• 14953170346931: PBD-1032-0812
• 14953170346924: PBD-1032-0811
• 14953170346917: PBD-1032-0810
• 14953170346900: PBD-1032-0809
• 14953170346894: PBD-1032-0808
• 14953170346887: PBD-1032-0807