CleanCision Wound Retraction and Protection System CC-M

GUDID 28685320003014

The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier prot

PRESCIENT SURGICAL, INC.

Radial surgical retractor Radial surgical retractor

• Primary Device ID: 28685320003014
• NIH Device Record Key: f8a313f5-a17e-4de9-9783-b45dc86de6cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CleanCision Wound Retraction and Protection System
• Version Model Number: FG 0002
• Catalog Number: CC-M
• Company DUNS: 078503474
• Company Name: PRESCIENT SURGICAL, INC.
• 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: (650) 999-0263
• Email: info@prescientsurgical.com
• Phone: (650) 999-0263
• Email: info@prescientsurgical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Cool, dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	18685320003017 [Primary]
GS1	28685320003014 [Package]; Contains: 18685320003017; Package: Shelf Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172132

FDA Product Code

• PQI: Wound Retraction And Protection System

Sterilization

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

[28685320003014]

Ethylene Oxide

[28685320003014]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-24

Devices Manufactured by PRESCIENT SURGICAL, INC.

• 28685320003007 - CleanCision™ Wound Retraction and Protection Syste: 2018-07-06 The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delive
• 28685320003014 - CleanCision Wound Retraction and Protection System: 2018-07-06The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier prot
• 28685320003014 - CleanCision Wound Retraction and Protection System: 2018-07-06 The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delive