Endoscope 5.5 MM Sterile, Reusable

GUDID 00699753018952

Terumo Cardiovascular Systems Corporation

Rigid reconstructive surgery endoscope

• Primary Device ID: 00699753018952
• NIH Device Record Key: 0efda458-f075-4617-aa38-6b7fbc2d636e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoscope 5.5 MM Sterile, Reusable
• Version Model Number: MCENDO550
• Company DUNS: 177655466
• Company Name: Terumo Cardiovascular Systems Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699753018952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160206

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

[00699753018952]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-12

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