Single Use Stent Insertion Kit V

GUDID 14953170347389

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic stent-placement system

• Primary Device ID: 14953170347389
• NIH Device Record Key: b9db1621-e112-45e6-b232-556844580dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Stent Insertion Kit V
• Version Model Number: MAJ-1818
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170347382 [Primary]
GS1	14953170347389 [Package]; Contains: 04953170347382; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103478

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC
• QGE: Biliary Stent, Drain, And Dilator Accessories

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 Stent Insertion Kit V]

• 14953170347419: MAJ-1821
• 14953170347402: Single Use Stent Insertion Kit V
• 14953170347396: MAJ-1819
• 14953170347389: MAJ-1818
• 14953170186551: Single Use Stent Insertion Kit V
• 14953170186537: Single Use Stent Insertion Kit V
• 14953170186513: MAJ-1420
• 14953170186490: Single Use Stent Insertion Kit V
• 14953170186476: MAJ-1418
• 14953170186452: Single Use Stent Insertion Kit V
• 14953170186438: Single Use Stent Insertion Kit V