Detachable endo pocket

GUDID 04714127863290

UNIMAX MEDICAL SYSTEMS INC.

Tissue extraction bag

• Primary Device ID: 04714127863290
• NIH Device Record Key: 17cfed2a-ea6b-4682-b9a2-ee6ccf9f11e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Detachable endo pocket
• Version Model Number: FEP934500
• 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: 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 Dimensions

• Height: 6 Inch
• Height: 6 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04714127863290 [Primary]
GS1	14714127863297 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	24714127863294 [Package]; Contains: 14714127863297; Package: Carton [10 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: 3
• Public Version Date: 2020-02-17
• Device Publish Date: 2019-01-22

On-Brand Devices [Detachable endo pocket]

• 24714127863584: FEP936114
• 24714127863546: FEP975924
• 24714127863508: FEP936116
• 04714127863290: FEP934500
• 24714127863065: FEP936116B