Home GUDID 28685320003014 CleanCision Wound Retraction and Protection System
Primary DI 28685320003014
Brand CleanCision Wound Retraction and Protection System
Company PRESCIENT SURGICAL, INC.
Model FG 0002
Catalog number CC-M
Device description The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier prot
Published 2018-04-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PQI Wound Retraction And Protection System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PQI Wound Retraction And Protection System General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 28685320003014 Package GS1 4 In Commercial Distribution 18685320003017 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 28685320003014 28685320003014 18685320003017 18685320003017
GMDN Terms# Term, Definition table Term Definition Radial surgical retractor A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Cool, dry environment
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 078503474 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00868532000307 CleanCision™ Wound Retraction and Protection System FG 0001 CC-S 2017-11-15 00868532000321 CleanCision Wound Retraction and Protection System FG 0002 CC-M 2018-04-24 28685320003007 CleanCision™ Wound Retraction and Protection Syste FG 0001 CC-S 2017-11-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00868532000321 CleanCision Wound Retraction and Protection System PRESCIENT SURGICAL, INC. PQI 2018-04-24 00868532000307 CleanCision™ Wound Retraction and Protection System PRESCIENT SURGICAL, INC. PQI 2017-11-15 28685320003007 CleanCision™ Wound Retraction and Protection Syste PRESCIENT SURGICAL, INC. PQI 2017-11-15
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