Single Use Injector NM600/610

GUDID 14953170378017

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, single-use

• Primary Device ID: 14953170378017
• NIH Device Record Key: 5191cf9b-f2cf-40ca-8404-b3615b0e90d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Injector NM600/610
• Version Model Number: NM-610U-1825
• 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
• 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	04953170378010 [Primary]
GS1	14953170378017 [Package]; Contains: 04953170378010; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153625

FDA Product Code

• FBK: endoscopic injection needle, gastroenterology-urology

Sterilization

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

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

On-Brand Devices [Single Use Injector NM600/610]

• 14953170378154: NM-610U-0426
• 14953170378130: NM-610U-0326
• 14953170378116: NM-610U-1826
• 14953170378093: NM-610U-0625
• 14953170378079: NM-610U-0525
• 14953170378055: NM-610U-0425
• 14953170378031: NM-610U-0325
• 14953170378017: NM-610U-1825
• 14953170377997: NM-610U-0623
• 14953170377973: NM-610U-0523
• 14953170377959: NM-610U-0423
• 14953170377935: NM-610U-0323
• 14953170377911: NM-610L-0426
• 14953170377898: NM-610L-0625
• 14953170377874: NM-610L-0525
• 14953170377850: NM-610L-0425
• 14953170377836: NM-610L-0623
• 14953170377812: NM-610L-0523
• 14953170377799: NM-610L-0423
• 14953170377775: NM-610L-0621
• 14953170377751: NM-610L-0521
• 14953170377737: NM-610L-0421
• 14953170377713: NM-600L-0625
• 14953170377690: NM-600L-0525
• 14953170377676: NM-600L-0425
• 14953170377652: NM-600L-0623
• 14953170377638: NM-600L-0523
• 14953170377614: NM-600L-0423
• 14953170377591: NM-600L-0621
• 14953170377577: NM-600L-0521
• 14953170377553: NM-600L-0421