FDA.reportPublic FDA data

CleanCision Wound Retraction and Protection System

Primary DI
00868532000321
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 protection and surgical retraction.
Published
2018-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQIWound Retraction And Protection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQIWound Retraction And Protection SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172132000CleanCision Wound Retraction and Protection SystemPrescient Surgical, Inc.2017-10-25PQI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868532000338PackageGS14In Commercial Distribution
00868532000321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868532000338008685320003388685320003380868532000338
00868532000321008685320003218685320003210868532000321

GMDN Terms#

Term, Definition table
TermDefinition
Radial surgical retractorA 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
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool, dry environment

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(650) 999-0263info@prescientsurgical.com

Regulatory Flags#

DUNS number
078503474
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868532000307CleanCision™ Wound Retraction and Protection SystemFG 0001CC-S2017-11-15
28685320003007CleanCision™ Wound Retraction and Protection SysteFG 0001CC-S2017-11-15
28685320003014CleanCision Wound Retraction and Protection SystemFG 0002CC-M2018-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
28685320003014CleanCision Wound Retraction and Protection SystemPRESCIENT SURGICAL, INC.PQI2018-04-24
00868532000307CleanCision™ Wound Retraction and Protection SystemPRESCIENT SURGICAL, INC.PQI2017-11-15
28685320003007CleanCision™ Wound Retraction and Protection SystePRESCIENT SURGICAL, INC.PQI2017-11-15