Versaport Plus 179097PF

GUDID 10884521081338

V2 Bladed Trocar with Fixation Cannula

Covidien LP

Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use Laparoscopic multi-instrument access port, single-use

• Primary Device ID: 10884521081338
• NIH Device Record Key: 754d7aa6-c140-4670-abb7-2972bf12430e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versaport Plus
• Version Model Number: 179097PF
• Catalog Number: 179097PF
• 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
• 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

• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Outer Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter

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
• 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	10884521081338 [Package]; Contains: 20884521081335; Package: CASE [3 Units]; In Commercial Distribution
GS1	20884521081335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062326

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: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [Versaport Plus]

• 10884521094505: Trocar Sleeve
• 10884521094475: Trocar Sleeve
• 10884521094451: Trocar Sleeve
• 10884521094284: Fixation Cannula
• 10884521094116: Fixation Cannula
• 10884521082687: Pyramidal Bladed Trocar with Fixation Cannula
• 10884521082670: Pyramidal Bladed Trocar
• 10884521082663: Pyramidal Bladed Trocar
• 10884521082656: Pyramidal Bladed Trocar
• 10884521082649: Pyramidal Bladed Trocar
• 10884521081376: V2 Bladed Obturator and Seal
• 10884521081369: V2 Bladed Obturator and Seal
• 10884521081338: V2 Bladed Trocar with Fixation Cannula
• 10884521081321: V2 Bladed Trocar
• 10884521081314: V2 Bladed Trocar with Fixation Cannula
• 10884521081307: V2 Bladed Trocar
• 10884521081291: V2 Bladed Trocar with Fixation Cannula
• 10884521081284: V2 Bladed Trocar
• 20884521076508: Bladeless Trocar
• 20884521076225: Bladeless Trocar
• 10884521094444: Trocar Sleeve
• 20884521076492: Bladeless Trocar with Fixation Cannula
• 10884521094178: Trocar Sleeve
• 10884521094109: Trocar Sleeve
• 20884521076546: Bladeless Trocar with Fixation Cannula
• 20884521076522: Bladeless Trocar with Fixation Cannula
• 20884521076485: Bladeless Trocar with Fixation Cannula
• 20884521076478: Bladeless Trocar with Fixation Cannula
• 20884521073958: Bladeless Trocar with Fixation Cannula
• 20884521073286: Fixation Cannula
• 20884521073194: Fixation Cannula
• 20884521075723: Bladeless Trocar with Fixation Cannula