ENDOCAPSULE SOFTWARE 10

GUDID 14953170373760

OLYMPUS MEDICAL SYSTEMS CORP.

Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software Video capsule endoscopy system application software

• Primary Device ID: 14953170373760
• NIH Device Record Key: 63743fce-4ede-4341-a874-56be39cedb5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOCAPSULE SOFTWARE 10
• Version Model Number: MAJ-2188
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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
• 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
• 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	04953170373763 [Primary]
GS1	14953170373760 [Package]; Contains: 04953170373763; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142680
• Premarket Notification: K183053

FDA Product Code

• NEZ: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

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

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

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170452932 - TRACHEAL INTUBATION FIBERSCOPE: 2024-04-22
• 14953170460064 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460088 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460101 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460132 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460330 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460378 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460613 - Single Use Biliary Drainage Stent V: 2024-04-02