FDA.reportPublic FDA data

EUROPCLIP

Primary DI
04250302286183
Brand
EUROPCLIP
Company
Ackermann Instrumente GmbH
Model
AI74CL6
Catalog number
AI74CL6
Device description
Large EUROPCLIPS, 6 titanium clips per cartridge, 20 cartridges per box
Published
2023-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPClip, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111930000ACKERMANN EUROPCLIPAckermann Instrumente GmbH2011-11-08FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250302286183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250302286183042503022861834250302286183

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315121009
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250302285025Ackermann Trockar Sleeve10-1117THC10-1117THC2023-11-13
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
04250302285995EUROPCLIP Applier13-1615AS2022-02-10
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
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225510MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
14026704725301WECKTELEFLEX INCORPORATEDFZP2025-07-03
14026704613868WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613875WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613844WECKTELEFLEX INCORPORATEDFZP2025-04-28
14026704613851WECKTELEFLEX INCORPORATEDFZP2025-04-24
14026704725264WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725271WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725288WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725295WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725318WECKTELEFLEX INCORPORATEDFZP2024-03-13
10193489144765MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144789MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144796MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144819MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20