SINGLE USE DISTAL COVER N6192001

GUDID 14953170467377

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope patient protection cap, single-use

• Primary Device ID: 14953170467377
• NIH Device Record Key: 76b5ff56-a673-48c4-b2bd-953dd3fe9e06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE DISTAL COVER
• Version Model Number: MAJ-2315
• Catalog Number: N6192001
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170467370 [Primary]
GS1	14953170467377 [Package]; Contains: 04953170467370; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253646

FDA Product Code

• FDT: Duodenoscope And Accessories, Flexible/Rigid

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: 2026-03-16
• Device Publish Date: 2026-03-06

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 14953170467377 - SINGLE USE DISTAL COVER: 2026-03-16
• 14953170467377 - SINGLE USE DISTAL COVER: 2026-03-16
• 04953170467288 - ULTRASONIC PROBE: 2026-01-29
• 04953170467318 - ULTRASONIC PROBE: 2026-01-29
• 14953170466219 - Single Use Cytology Brush V: 2026-01-27
• 14953170466349 - Single Use 3-Lumen Needle Knife V: 2025-12-26
• 14953170466356 - Single Use 3-Lumen Needle Knife V: 2025-12-26
• 04953170465277 - AUXILIARY WATER TUBE: 2025-12-15
• 04953170421815 - Reusable Cordless Transducer: 2025-12-12