ANTENNA LEAD COVER

GUDID 04953170214325

OLYMPUS MEDICAL SYSTEMS CORP.

Video capsule endoscopy system antenna

• Primary Device ID: 04953170214325
• NIH Device Record Key: e245dff6-b99d-430c-9a2e-757f514a2a04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTENNA LEAD COVER
• Version Model Number: MAJ-1470
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 50
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170214325 [Primary]
GS1	84953170214321 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090210
• Premarket Notification: K183053

FDA Product Code

• NEZ: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-10-06

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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• 04953170433412 - VISERA ELITE III LED LIGHT SOURCE: 2025-04-25
• 04953170445453 - OTV-S700 UPGRADE PACK 3D: 2025-04-25
• 04953170467271 - PROBE DRIVING UNIT: 2025-04-24
• 04953170431760 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER: 2025-04-11
• 04953170431883 - CHE SOFTWARE OPTION: 2025-04-11
• 04953170431890 - ELST SOFTWARE OPTION: 2025-04-11