FDA.reportPublic FDA data

KIT KE226 COLON

Primary DI
20607915133898
Brand
KIT KE226 COLON
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
GK253
Device description
Kit Contains:C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BXC4130, 5mmx35cm EPIX LAPA GRASPER, 10/BXCB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BXCFF73, 12x100 Kii Fios ADVFIX 6/BXCFF03, 5x100 Kii Fios ADVFIX 6/BXCFF33, 11X100 Kii Fios ADVFIX 6/BXCY010, 5mmX35cm EPIX LAPA DISSECT, 10/BXC2201, 120MM INSUFF NEEDLE XE, 20/BXCA090, DIRECT DRIVE LCA 3/BXC8702, M ALEXIS LAP SYS W/Kii Fios 5/BX
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHFSystem, Evacuator, Fluid
FZPClip, Implantable
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories
HETLaparoscope, Gynecologic (And Accessories)
KKXDrape, Surgical
MDMInstrument, Manual, Surgical, General Use
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2
FZPClip, ImplantableGeneral, Plastic Surgery2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
KKXDrape, SurgicalGeneral, Plastic Surgery2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607915133898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060791513389820607915133898

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

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