Versaport ONBFCA12LG

GUDID 20884521181356

Bladeless Optical Fixation Cannula

Covidien LP

Laparoscopic access cannula, single-use

• Primary Device ID: 20884521181356
• NIH Device Record Key: c92739f3-cc6b-4720-93a5-f28323d899c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versaport
• Version Model Number: ONBFCA12LG
• Catalog Number: ONBFCA12LG
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521181359 [Primary]
GS1	20884521181356 [Package]; Contains: 10884521181359; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130435

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: 2020-01-09
• Device Publish Date: 2016-09-24

On-Brand Devices [Versaport]

• 10884521094437: Fixation Cannula
• 10884521094406: Fixation Cannula
• 10884521093591: Trocar Sleeve
• 10884521093584: Trocar Sleeve
• 10884521081352: V2 Bladed RT Obturator
• 10884521081345: V2 Bladed RT Obturator
• 10884521081277: V2 Bladed Trocar with Fixation Cannula
• 10884521081260: V2 Bladed Trocar
• 10884521081253: V2 Bladed Trocar with Fixation Cannula
• 10884521081246: V2 Bladed Trocar
• 10884521078529: Reusable Cannula
• 10884521078420: Reusable Cannula
• 20884521215402: Universal Fixation Cannula
• 20884521215396: Universal Fixation Cannula
• 20884521215389: Universal Fixation Cannula
• 20884521181356: Bladeless Optical Fixation Cannula
• 20884521181349: Bladeless Optical Trocar with Fixation Cannula
• 20884521181332: Bladeless Optical Trocar with Fixation Cannula
• 20884521181325: Bladeless Optical Fixation Cannula
• 20884521134260: Bladeless Optical Fixation Cannula
• 20884521134253: Bladeless Optical Fixation Cannula
• 20884521134246: Bladeless Optical Trocar with Fixation Cannula
• 20884521134239: Bladeless Optical Trocar with Fixation Cannula
• 20884521134222: Bladeless Optical Trocar with Fixation Cannula
• 20884521134215: Bladeless Optical Trocar with Fixation Cannula
• 20884521134277: Bladeless Optical Fixation Cannula
• 10884521078543: Reusable Cannula
• 10884521078383: Reusable Cannula
• 10884521094420: Trocar Sleeve
• 10884521078536: Reusable Cannula
• 10884521078475: Reusable Cannula
• 10884521078468: Reusable Cannula
• 10884521078451: Reusable Cannula
• 10884521078444: Reusable Cannula
• 10884521078437: Reusable Cannula
• 10884521078390: Reusable Cannula
• 10884521078376: Reusable Cannula
• 20884521181400: Bladeless Optical Fixation Cannula
• 20884521181394: Bladeless Optical Trocar with Fixation Cannula
• 20884521181387: Bladeless Optical Trocar with Fixation Cannula
• 20884521181370: Bladeless Optical Trocar with Smooth Cannula
• 20884521181363: Bladeless Optical Trocar with Fixation Cannula
• 10884521134553: Reusable Cannula
• 10884521078512: Reusable Cannula
• 10884521094314: Trocar Sleeve
• 20884521076744: Bladeless Trocar with Fixation Cannula
• 20884521076737: Bladeless Trocar with Fixation Cannula
• 20884521076720: Bladeless Trocar with Fixation Cannula
• 20884521073514: Fixation Cannula
• 20884521073507: Fixation Cannula