Intra-Art Coronary Artery Retraction Clip

Primary DI
B040CRC52
Brand
Intra-Art Coronary Artery Retraction Clip
Company
GENESEE BIOMEDICAL, INC.
Model
CRC-5
Device description
Coronary Artery Retraction Clip
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882981000PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPPioneering Technologies, Inc.1988-09-27DWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040CRC52PackageHIBCC1In Commercial Distribution
B040CRC51PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery exposure retractorA sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 786-4890info@geneseebiomedical.com

Regulatory Flags#

DUNS number
939872651
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
true
Sterilization required before use
false

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