Speculum Tubing

GUDID 00817688021360

I.C. MEDICAL, INC.

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• Primary Device ID: 00817688021360
• NIH Device Record Key: d77a4298-cbd3-46a7-ae92-f7191cf57329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speculum Tubing
• Version Model Number: ICM-000-0021
• 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: true
• Expiration Date: false
• 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	00817688021353 [Primary]
GS1	00817688021360 [Package]; Contains: 00817688021353; Package: [9 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: true
• Device Is Sterile: false

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

[00817688021360]

Ethylene Oxide

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