DISPOSABLE DISTAL ATTACHMENT N3528941

GUDID 14953170454278

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope distal observation spacer, single-use

• Primary Device ID: 14953170454278
• NIH Device Record Key: 08d5dd32-4319-4cd0-8068-df2ec46ed421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Version Model Number: D-201-10704
• Catalog Number: N3528941
• 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
• 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	04953170454271 [Primary]
GS1	14953170454278 [Package]; Contains: 04953170454271; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250296

FDA Product Code

• FDS: Gastroscope 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: 2025-05-20
• Device Publish Date: 2025-05-12

On-Brand Devices [DISPOSABLE DISTAL ATTACHMENT]

• 14953170278324: DISPOSABLE DISTAL ATTACHMENT
• 14953170278317: DISPOSABLE DISTAL ATTACHMENT
• 14953170278300: D-201-13404
• 14953170278294: DISPOSABLE DISTAL ATTACHMENT
• 14953170278287: DISPOSABLE DISTAL ATTACHMENT
• 14953170278270: DISPOSABLE DISTAL ATTACHMENT
• 14953170278263: DISPOSABLE DISTAL ATTACHMENT
• 14953170048521: D-201-16403
• 14953170048422: D-201-12402
• 14953170048392: D-201-11802
• 14953170453912: D-201-16403
• 14953170453905: D-201-15004
• 14953170453899: D-201-14304
• 14953170453882: D-201-13404
• 14953170453875: D-201-12704
• 14953170453868: D-201-12402
• 14953170453851: D-201-11804
• 14953170453844: D-201-11802
• 14953170453837: D-201-11304
• 14953170453820: D-201-10704
• 14953170454346: D-201-14304
• 14953170454322: D-201-12704
• 14953170454308: D-201-11804
• 14953170454292: D-201-11802
• 14953170454285: D-201-11304
• 14953170454278: D-201-10704
• 14953170454353: D-201-15004