FDA.reportPublic FDA data

EUROPCLIP Applier

Primary DI
04250302285995
Brand
EUROPCLIP Applier
Company
Ackermann Instrumente GmbH
Model
13-1615AS
Device description
Clip Applicator for Medium Large Clips, Rotatable, Double Action,330 mm, Ø10,0 mm
Published
2022-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBTApplier, Hemostatic Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBTApplier, Hemostatic ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250302285995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250302285995042503022859954250302285995

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic surgical ligation clip applier, reusableA hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461966170info@ackermanninstrumente.de

Regulatory Flags#

DUNS number
315121009
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250302285025Ackermann Trockar Sleeve10-1117THC10-1117THC2023-11-13
04250302286183EUROPCLIPAI74CL6AI74CL62023-03-02
04250302286459EUROPCLIPAI74CS6AI74CS62022-09-15
04250302285889ETH NEEDLE HOLDER13-1591ET-452022-06-23
04250302285896ETH NEEDLE HOLDER13-1593ET2022-02-10
04250302285919ETH NEEDLE HOLDER13-1594ET2022-02-10
04250302285971EUROPCLIP Applier13-1613-105AS2022-02-10
04250302285988EUROPCLIP Applier13-1610AS13-1610AS2022-02-10
04250302286008EUROPCLIP Applier13-1613-106AS2022-02-10
04251852735947EUROPCLIP Applier13-1610AS13-1610AS2022-02-03
04250302285872ETH NEEDLE HOLDER13-1591ET2022-01-31
04250302280556ETH NEEDLE HOLDER13-1591ET2022-01-31
04250302234139EUROPCLIPAI74CS6AI74CS62017-02-13
04250302234146EUROPCLIPAI74CM6AI74CM62017-02-13
04250302234153EUROPCLIPAI74CML6AI74CML62017-02-13
04250302234160EUROPCLIPAI74CL6AI74CL62017-02-13
04250302200004ENDOLOCK13-1300I13-1300I2017-02-14
04250302201469ENDOLOCK13-1301I13-1301I2017-02-14
04250302201483SECULOCK13-1321SQI13-1321SQI2017-03-07
04250302202169SECULOCK13-1383SQ13-1383SQ2017-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661522100882Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100899Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100905Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100929Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100936Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100912Applier, hemostatic clipPETERS SURGICALHBT2023-12-28
03661522039540Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039557Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039564Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039571Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039588Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039595Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039601Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039649Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039656Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039663Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039670Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039687Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039694Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039700Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039717Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039724Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039731Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039748Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039755Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039762Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039786Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039793Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039809Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039816Applier, hemostatic clipPETERS SURGICALHBT2023-06-08