TROGARD FINESSE 60-6050-006

GUDID 20653405011931

TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 5MM

Conmed Corporation

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use

• Primary Device ID: 20653405011931
• NIH Device Record Key: 05082eed-938a-40fa-934d-e6c308336962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TROGARD FINESSE
• Version Model Number: 60-6050-006
• Catalog Number: 60-6050-006
• 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 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• 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
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405011937 [Unit of Use]
GS1	20653405011931 [Package]; Contains: 30653405011938; Package: BOX [6 Units]; In Commercial Distribution
GS1	30653405011938 [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

[20653405011931]

Ethylene Oxide

[20653405011931]

Ethylene Oxide

[20653405011931]

Ethylene Oxide

[20653405011931]

Ethylene Oxide

[20653405011931]

Ethylene Oxide

[20653405011931]

Ethylene Oxide

[20653405011931]

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

On-Brand Devices [TROGARD FINESSE]

• 20653405012044: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYESTEM, 10/11MM
• 20653405012037: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYESTEM, 5MM
• 20653405011979: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 10/12MM
• 20653405011955: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 10/11MM
• 20653405011931: TROGARD FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 5MM
• 20653405036422: TROGARD MINI-FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 5MM