FDA.reportPublic FDA data

Ackermann Trockar Sleeve

Primary DI
04250302285025
Brand
Ackermann Trockar Sleeve
Company
Ackermann Instrumente GmbH
Model
10-1117THC
Catalog number
10-1117THC
Device description
Trocar with silicon valve, dismountable,12.5 mm,
Published
2023-11-13
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974382000ACKERMANN SURGICAL INSTRUMENTSAckermann Instrumente GmbH1998-04-21GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250302285025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250302285025042503022850254250302285025

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. 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
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
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
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B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
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B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
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00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24
00190776421663MillenniumAvalign Technologies, Inc.GCJ2026-06-23