SurgiSleeve WPLG914

GUDID 20884521164816

Large Wound Protector

Covidien LP

Radial surgical retractor Radial surgical retractor

• Primary Device ID: 20884521164816
• NIH Device Record Key: 9ef9330e-954e-4623-b2fd-d5ee0f1d4e75
• Commercial Distribution Discontinuation: 2019-08-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SurgiSleeve
• Version Model Number: WPLG914
• Catalog Number: WPLG914
• 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

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521164819 [Package]; Contains: 30884521164813; Package: CASE [12 Units]; Discontinued: 2019-08-06; Not in Commercial Distribution
GS1	20884521164816 [Package]; Contains: 30884521164813; Package: PACK_OR_INNER_PACK [5 Units]; Discontinued: 2019-08-06; Not in Commercial Distribution
GS1	30884521164813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120061

FDA Product Code

• GCI: LARYNGOSCOPE, ENDOSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-06
• 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