TROGARD 60-6050-081

GUDID 20653405011993

TROGARD BLUNT TIP TROCAR SYSTEM, 10/11MM X 120MM

Conmed Corporation

Laparoscopic access cannula, single-use

• Primary Device ID: 20653405011993
• NIH Device Record Key: 0023fb6c-7c39-4d0e-96a1-24bd20546d2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TROGARD
• Version Model Number: 60-6050-081
• Catalog Number: 60-6050-081
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 6
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405011999 [Unit of Use]
GS1	20653405011993 [Package]; Contains: 30653405011990; Package: BOX [6 Units]; In Commercial Distribution
GS1	30653405011990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001597

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

[20653405011993]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 10653405008125 - NA: 2024-12-04 CONMED REUSABLE DISPERSIVE ELECTRODE
• 10653405008132 - NA: 2024-12-04 CONMED REUSABLE PEDIATRIC DISPERSIVE ELECTRODE
• 30653405987585 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405987592 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 30653405987608 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405990141 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 20653405990120 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
• 20653405990137 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm