WATER CONTAINER (CAP AND TUBE)

GUDID 04953170025563

GX9538 WATER CONT. W/CLIP & O RING

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic irrigation/distension bottle

• Primary Device ID: 04953170025563
• NIH Device Record Key: fff971ae-ec77-447a-ad15-74073c66ed00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATER CONTAINER (CAP AND TUBE)
• Version Model Number: MA-995
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170025563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053382

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04953170025563]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-21

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