ENDOSCOPE POSITION DETECTING UNIT

GUDID 04953170305641

OLYMPUS MEDICAL SYSTEMS CORP.

Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system Gastrointestinal catheter/endoscope tracking system

• Primary Device ID: 04953170305641
• NIH Device Record Key: 86a26db3-8118-49e7-b73a-c5e7c0f38608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSCOPE POSITION DETECTING UNIT
• Version Model Number: UPD-3
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: +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	04953170305641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134026

FDA Product Code

• FDF: Colonoscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [ENDOSCOPE POSITION DETECTING UNIT]

• 04953170331145: UPD-3
• 04953170331121: UPD-3
• 04953170305641: UPD-3
• 04953170303043: UPD-3