DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME

GUDID 14953170041645

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170041645
• NIH Device Record Key: 64107f1e-1425-4d0d-9141-dbc6e4a716a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
• Version Model Number: KD-401Q-0720
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170041648 [Primary]
GS1	14953170041645 [Package]; Contains: 04953170041648; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without 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: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME]

• 14953170042390: KD-431Q-0730
• 14953170042369: KD-431Q-0720
• 14953170042062: KD-411Q-0320
• 14953170042000: KD-411Q-0320
• 14953170041942: KD-411Q-0320
• 14953170041706: KD-401Q-0730
• 14953170041645: KD-401Q-0720
• 14953170041614: KD-401Q-0330
• 14953170041584: KD-401Q-0320
• 14953170464567: KD-411Q-0320
• 14953170463775: KD-431Q-0720
• 14953170463768: KD-411Q-0320