Occlutech Pistol Pusher

Primary DI
08683463400208
Brand
Occlutech Pistol Pusher
Company
OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
Model
38PP185
Catalog number
38PP185
Device description
The Occlutech Pistol Pusher is a medical device compatible with the Occlutech Atrial Septal Defect Occluder (Occlutech ASD Occluder) and applications with special cardiac catheters in the human heart.The Occlutech Pistol Pusher is composed of proximal body and distal parts. The distal part consists of titanium alloy jaws and a stainless-steel container while the body part is polymer laminated stainless steel coil. The proximal parts of the Occlutech Pistol Pusher largely contains plastic components. The jaws and container mechanism grab and secure the ball connector of the compatible Occlutech ASD Occluder and allow retraction of the Occlutech ASD Occluder into the ODS III and advancement to the implant area. The proximal part has a trigger for releasing the compatible Occlutech ASD Occluder and a locking mechanism for locking the system to prevent unintentional release. The Occlutech Pistol Pusher is available in different sizes for compatibility with the Occlutech ASD Occluders.
Published
2024-03-05
Public version status
New
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
OZGTranscatheter Septal Occluder (Atrial)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZGTranscatheter Septal Occluder (Atrial)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200032000Occlutech® ASD Occluder and Occlutech® Pistol PusherOcclutech Holding AG2023-12-29OZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08683463400208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08683463400208086834634002088683463400208

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac defect occluderAn implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Centimeter
Outer Diameter2.93Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Dry and Away from Sunlight
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-836-2228xx@xx.xx

Regulatory Flags#

DUNS number
502656748
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08683463400161Occlutech Pistol Pusher38PP12538PP1252024-03-05
08683463400185Occlutech Pistol Pusher38PP16538PP1652024-03-05
08683463400222Occlutech Pistol Pusher38PP21038PP2102024-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260182521540Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521557Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521564Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521571Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521588Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521595Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521601Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521618Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521625Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521632Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521649Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521656Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521663Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521670Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521687Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
07340175601941Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601958Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601965Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601972Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601989Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601996Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602009Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602016Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602023Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602030Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602047Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602054Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602061Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602078Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602085Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05