SurgiSleeve

GUDID 20884521521718

Extra Large Wound Protector with Retracting Ring

Covidien LP

Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor Radial surgical retractor

• Primary Device ID: 20884521521718
• NIH Device Record Key: 1a6a6a21-70e4-41a4-9370-16722b019e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiSleeve
• Version Model Number: WPLGR914
• 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: false
• 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

Device Dimensions

• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter
• Outer Diameter: 14 Centimeter
• Outer Diameter: 9 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521521711 [Primary]
GS1	20884521521718 [Package]; Contains: 10884521521711; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143091

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: 2022-08-08
• Device Publish Date: 2016-09-24

On-Brand Devices [SurgiSleeve]

• 20884521164816: Large Wound Protector
• 10884521203792: Extra Small Wound Protector
• 30884521164837: Small Wound Protector
• 30884521164820: Medium Wound Protector
• 20884521521718: Extra Large Wound Protector with Retracting Ring
• 20884521521725: Large Wound Protector with Retracting Ring