Speculum Tubing ICM-000-0418

GUDID 00817688021421

I.C. MEDICAL, INC.

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• Primary Device ID: 00817688021421
• NIH Device Record Key: 44d6779e-23e1-42ac-8346-885bdc3d8163
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speculum Tubing
• Version Model Number: 2195
• Catalog Number: ICM-000-0418
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817688021414 [Primary]
GS1	00817688021421 [Package]; Contains: 00817688021414; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930098

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: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Speculum Tubing]

• 00817688021421: 2195
• 00817688021407: ICM-000-0365
• 00817688021384: ICM-000-0027
• 00817688021360: ICM-000-0021
• 00817688022947: Speculum Tubing, 22mm to 10mm Connector, Sterile