Single Use Aspiration Needle NA-U401SX R5000691

GUDID 14953170409971

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, single-use

• Primary Device ID: 14953170409971
• NIH Device Record Key: 3f730c0b-8845-4d22-bf3c-66ea19ffe59a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Aspiration Needle NA-U401SX
• Version Model Number: NA-U401SX-4021
• Catalog Number: R5000691
• 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
• 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	04953170409974 [Primary]
GS1	14953170409971 [Package]; Contains: 04953170409974; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160098

FDA Product Code

• FCG: Biopsy Needle

Sterilization

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

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

[14953170409971]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-11
• Device Publish Date: 2024-07-03

On-Brand Devices [Single Use Aspiration Needle NA-U401SX]

• 14953170388320: NA-U401SX-4022
• 14953170388283: NA-U401SX-4022
• 14953170388245: NA-U401SX-4021
• 14953170409995: NA-U401SX-4022
• 14953170409988: NA-U401SX-4022
• 14953170409971: NA-U401SX-4021