FDA.reportPublic FDA data

Accu-Beam

Primary DI
B17798510
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
9851
Device description
22 Gauge x 36cm Needle.
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K934398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934398000ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLETransamerican Technologies Intl.1994-02-14GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B17798510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, reusableA flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
130213366
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1779450F0Accu-Surg9450F2026-04-21
B177700500180Accu-Beam700500182026-04-14
B177950134700Accu-Beam9501-34/702022-02-23
B177950150700Accu-Beam9501-50/702020-06-30
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
B17781860Accu-Beam81862020-05-19
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B177301650T5320Accu-Beam301650T-5322021-11-19
B1773122602B0Accu-Beam31226-02B 2021-06-25
B1773126002B0Accu-Beam31260-02B 2021-06-25
B1778194101M0Accu-Beam8194101M2019-05-30
B1778194101M010Accu-Beam8194101M-012019-05-30
B1772000029800Accu-Beam2000029802019-01-25
B1772000039490Accu-Beam2000039492019-01-15
B1772010TTI0Accu-Beam2010TTI2018-07-25
B17725045120Accu-Beam25045122018-08-27
B17725045130Accu-Beam25045132018-08-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
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08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
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08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
10886705030187NAMedos International SàrlGCJ2018-02-22