FDA.reportPublic FDA data

Endoch

Primary DI
B747EAI0535
Brand
Endoch
Company
Endoch Inc
Model
EAI-0535
Catalog number
EAI-0535
Device description
DISPOSABLE MONOPOLAR LAPAROSCOPIC FORCEPS
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B747EAI0535PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic grasping forceps, single-useA sterile, rigid manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument. It is typically made of metal and plastic materials and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241382683
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GS3300EndochGS-330GS-3302019-06-01
GS3309EndochGS-330BGS-330B2019-06-01
GS4300EndochGS-430GS-4302019-06-01
GS4307EndochGS-430LGS-430L2019-06-01
GS5000EndochGS-500GS-5002019-06-01
GS5007EndochGS-500LGS-500L2019-06-01
B747EAI0496EndochEAI-0496EAI-04962019-10-01
B747EAI0502EndochEAI-0502EAI-05022019-10-01
B747EAI0503EndochEAI-0503EAI-05032019-10-01
B747EAI0628EndochEAI-0628EAI-06282019-10-01
B747EAI0784EndochEAI-0784EAI-07842019-10-01
B747EAI0785EndochEAI-0785EAI-07852019-10-01
B747EAI0787EndochEAI-0787EAI-07872019-10-01
B747EAI0788EndochEAI-0788EAI-07882019-10-01
B747EAI0793Endoch EAI-0793EAI-07932019-10-01
DGF23181EndochDGF-2318ADGF-2318A2019-06-03
DGF231858EndochDGF-2318RTDGF-2318RT2019-06-03
DGF23189EndochDGF-2318GDGF-2318G2019-06-03
DGF23231EndochDGF-2323ADGF-2323A2019-06-03
DGF232358EndochDGF-2323RTDGF-2323RT2019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09