Femcare

GUDID 24714127864970

UNIMAX MEDICAL SYSTEMS INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 24714127864970
• NIH Device Record Key: 18db1b48-58b7-497e-8329-7e3e10b66efb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femcare
• Version Model Number: FN-100-212
• Company DUNS: 658122465
• Company Name: UNIMAX MEDICAL SYSTEMS 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	14714127864973 [Primary]
GS1	24714127864970 [Package]; Contains: 14714127864973; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112358

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: 4
• Public Version Date: 2020-02-17
• Device Publish Date: 2019-08-15

On-Brand Devices [Femcare]

• 24714127864987: FN-100-211
• 24714127864970: FN-100-212
• 24714127864963: FN-100-209
• 24714127862495: FN-100-210