Monopolar scissors

GUDID 24714127865984

UNIMAX MEDICAL SYSTEMS INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 24714127865984
• NIH Device Record Key: 5bef7cbc-bf57-4663-b12c-03e6e548f578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar scissors
• Version Model Number: FMS333050
• 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

• Length: 33 Centimeter
• Length: 33 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04714127865980 [Primary]
GS1	14714127865987 [Package]; Contains: 04714127865980; Package: box [10 Units]; In Commercial Distribution
GS1	24714127865984 [Package]; Contains: 14714127865987; Package: carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103508

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-02-17
• Device Publish Date: 2017-09-18

On-Brand Devices [Monopolar scissors]

• 24714127868466: FMS333057
• 24714127867124: FMS333054
• 24714127865984: FMS333050
• 24714127862990: FMS433055
• 04714127862989: FMS445055
• 24714127862976: FMS433056