Sheath section

GUDID 04953170033971

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable General-purpose endoscopic needle, reusable

• Primary Device ID: 04953170033971
• NIH Device Record Key: b6ee1394-e35a-44e0-978e-e25f32a5a720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheath section
• Version Model Number: MAJ-69
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170033971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011484

FDA Product Code

• GAA: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Sterilization

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

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

Moist Heat or Steam Sterilization

[04953170033971]

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 [Sheath section]

• 04953170033971: MAJ-69
• 04953170033810: MAJ-074 SHEATH FOR INJECTION NEED NM-8/9