Attacha Vac 212009J

GUDID 00817688022268

ICM-000-0412

I.C. MEDICAL, INC.

Surgical plume evacuation system tube

• Primary Device ID: 00817688022268
• NIH Device Record Key: 8897c170-f0e2-43df-9660-2060afc465db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Attacha Vac
• Version Model Number: 212009J
• Catalog Number: 212009J
• 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	00817688021216 [Previous]
GS1	00817688022268 [Primary]
GS1	00817688022275 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953418

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2017-09-15

On-Brand Devices [Attacha Vac]

• 00817688022299: ICM-000-0438
• 00817688022268: ICM-000-0412
• 00817688021247: 2120-09EC
• 00817688021223: 2120-09