Gas Filter Unit ACC-GFU-100

GUDID 10894338002693

Gas Filter Unit, Box of 10

OMNIGUIDE, INC.

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• Primary Device ID: 10894338002693
• NIH Device Record Key: 678ad991-8ed6-406b-b5a6-ac9bbb631c26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gas Filter Unit
• Version Model Number: ACC-GFU-100
• Catalog Number: ACC-GFU-100
• Company DUNS: 030124221
• Company Name: OMNIGUIDE, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894338002733 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	10894338002693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073409

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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• 10894338002693 - Gas Filter Unit: 2018-07-06Gas Filter Unit, Box of 10
• 10894338002693 - Gas Filter Unit: 2018-07-06 Gas Filter Unit, Box of 10