ESU Shroud

GUDID 00817688021995

I.C. MEDICAL, INC.

Surgical plume evacuation system tube

• Primary Device ID: 00817688021995
• NIH Device Record Key: f1a9a999-1d80-49f4-af84-ff0eb12335a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESU Shroud
• Version Model Number: ICM-000-0543
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 25
• 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	00817688021278 [Unit of Use]
GS1	00817688021995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953418

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

Ethylene Oxide

[00817688021995]

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 [ESU Shroud]

• 00817688022404: ICM-000-0560
• 00817688021995: ICM-000-0543
• 00817688021988: ICM-000-0542
• 00817688021971: ICM-000-0449
• 00817688021940: ICM-000-0175
• 00817688021933: ICM-000-0101
• 00817688021209: ICM-000-0357
• 00817688021186: ICM-000-0301E
• 00817688021162: ICM-000-0226
• 00817688021124: ICM-000-0169
• 00817688021100: ICM-000-0166
• 00817688021087: ICM-000-0148
• 00817688021063: ICM-000-0017
• 00817688022497: ICM-000-0568
• 00817688022657: ESU Shroud, Short Tip, 1’ Tube, Sterile