BILIARY DRAINAGE TUBE SET

GUDID 04953170047213

OLYMPUS MEDICAL SYSTEMS CORP.

Biliary drainage catheter Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system Endoscopic stent-placement system

• Primary Device ID: 04953170047213
• NIH Device Record Key: 7713d2cb-bc2e-4fb4-89f2-33272d7091f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BILIARY DRAINAGE TUBE SET
• Version Model Number: MAJ-511
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170047213 [Primary]
GS1	14953170047210 [Package]; 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: true
• Device Is Sterile: true

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

[04953170047213]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [BILIARY DRAINAGE TUBE SET]

• 04953170047213: MAJ-511
• 04953170047183: MAJ-508
• 04953170045288: MAJ-256