Robotic Tool Kit Knot Pusher Open

Primary DI
B040RTKKPO1
Brand
Robotic Tool Kit Knot Pusher Open
Company
GENESEE BIOMEDICAL, INC.
Model
RTK-KPO
Device description
Suture Knot Pusher with Open Tip
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040RTKKPO1PackageHIBCC1In Commercial Distribution
B040RTKKPO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
939872651
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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B040RPS18900Thoracic Port with Obturator 18x90mmRPS-18902026-03-25
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B040TF320TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF340TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF380TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF400TransForm McCarthy Annuloplasty RingTF-402024-12-23
B040TF240TransForm McCarthy Annuloplasty RingTF-242024-12-23
B040TF26TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF28TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF30TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF32TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF34TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF360TransForm McCarthy Annuloplasty RingTF-362024-12-23
B040TF38TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF40TransForm McCarthy Annuloplasty RingTF-402024-12-23

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