PAPILLOTOMY KNIFE

GUDID 14953170038157

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 14953170038157
• NIH Device Record Key: 8b4ae517-e37c-449b-bca6-3c4ace3b8822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAPILLOTOMY KNIFE
• Version Model Number: KD-16Q-1
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 2
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170038150 [Primary]
GS1	14953170038157 [Package]; Contains: 04953170038150; Package: [1 Units]; In Commercial Distribution
GS1	84953170038156 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955247

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

Moist Heat or Steam Sterilization

[14953170038157]

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 [PAPILLOTOMY KNIFE]

• 14953170038850: KD-30Q-1
• 14953170038751: KD-28Q-1
• 14953170038706: KD-27Q-1.B PUSH TYPE SPHINCTEROTOME W/ST
• 14953170038454: KD-22Q-1
• 14953170038409: KD-21Q-1
• 14953170038300: KD-19Q-1
• 14953170038256: KD-18Q-1
• 14953170038201: KD-17Q-1
• 14953170038157: KD-16Q-1