Single Use Guiding Device

GUDID 14953170406178

OLYMPUS MEDICAL SYSTEMS CORP.

Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use Bronchoscopic biopsy curette, flexible, single-use

• Primary Device ID: 14953170406178
• NIH Device Record Key: ccb7ec2b-83a1-46e9-a564-7febddef2935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Guiding Device
• Version Model Number: CC-220DR
• 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
• 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
• 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	04953170406171 [Primary]
GS1	14953170406178 [Package]; Contains: 04953170406171; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192164

FDA Product Code

• BTG: Brush, biopsy, bronchoscope (non-rigid)

Sterilization

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

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

[14953170406178]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-15
• Device Publish Date: 2021-09-07

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