Detachable endo pocket (Nylon)

GUDID 24714127863287

UNIMAX MEDICAL SYSTEMS INC.

Tissue extraction bag

• Primary Device ID: 24714127863287
• NIH Device Record Key: 0d2cb32e-24ba-4c65-a97d-938504a269fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Detachable endo pocket (Nylon)
• Version Model Number: FEPC81080
• 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 Dimensions

• Height: 10 Inch
• Height: 10 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04714127863283 [Primary]
GS1	14714127863280 [Package]; Contains: 04714127863283; Package: Box [5 Units]; In Commercial Distribution
GS1	24714127863287 [Package]; Contains: 14714127863280; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103510

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: 2017-01-09

Devices Manufactured by UNIMAX MEDICAL SYSTEMS INC.

• 14714127861507 - Unimax: 2025-02-14 CapSure rip-stop detachable endo pocket
• 14714127866007 - Unimax: 2024-08-07 Monopolar Scissors
• 14714127863150 - blue endo: 2024-06-28 Anti fog solution alcohol free
• 14714127863181 - blue endo: 2024-06-28 Smoke evacuation tubing
• 14714127861460 - BluView: 2023-03-17 Cannula_15mm/10cm
• 14714127861736 - BluView: 2023-03-02 CANNULA ONLY 5-12+MM/70MM
• 14714127860333 - BluView: 2023-02-13 OPTICAL TROCAR
• 14714127860364 - BluView: 2023-02-13 CANNULA ONLY 5-12+MM/150MM