HEAT PROBE

GUDID 14953170037624

OLYMPUS MEDICAL SYSTEMS CORP.

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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• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17
• 04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip: 2024-09-17
• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
• 14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 14953170409971 - Single Use Aspiration Needle NA-U401SX: 2024-07-11