OmniClose trocar site closure device

GUDID 24714127867957

UNIMAX MEDICAL SYSTEMS INC.

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use

• Primary Device ID: 24714127867957
• NIH Device Record Key: 04107ba2-8df7-44d6-a2fe-87e758e24572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniClose trocar site closure device
• Version Model Number: FCL215000
• Company DUNS: 658122465
• Company Name: UNIMAX MEDICAL SYSTEMS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	04714127867953 [Primary]
GS1	14714127867950 [Package]; Contains: 04714127867953; Package: Box [10 Units]; In Commercial Distribution
GS1	24714127867957 [Package]; Contains: 14714127867950; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• GDF: Guide, Needle, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-09
• Device Publish Date: 2018-04-02

On-Brand Devices [OmniClose trocar site closure device]

• 24714127867957: FCL215000
• 24714127867292: FCL200000
• 24714127867285: FCL201100