HEAT PROBE

GUDID 14953170037624

OLYMPUS MEDICAL SYSTEMS CORP.

Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode Electrocautery system electrode

• Primary Device ID: 14953170037624
• NIH Device Record Key: ab7a1f93-6a1b-403a-a379-4cc47ba7608d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEAT PROBE
• Version Model Number: CD-110U
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• 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	04953170037627 [Primary]
GS1	14953170037624 [Package]; Contains: 04953170037627; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982289

FDA Product Code

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

Sterilization

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

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

Moist Heat or Steam Sterilization

[14953170037624]

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

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