FDA.reportPublic FDA data

KIT KE211 COLE 5MM

Primary DI
20607915135113
Brand
KIT KE211 COLE 5MM
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
GK273
Device description
Kit Contains:CTB33, 11X100 Kii SH BLD ZTHR 6/BXCTB12, 5x100 Kii SH BLD ZTHR DP 10/BXCTS02, 5x100 Kii SLEEVE ZTHR 12/BXC6001, 5mmX33cm PROB/VALV DUAL BAG 12/BXC2201, 120MM INSUFF NEEDLE XE, 20/BXCB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BXCY010, 5mmX35cm EPIX LAPA DISSECT, 10/BXCA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/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)
MDMInstrument, Manual, Surgical, General Use

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
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607915135113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060791513511320607915135113

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic electrosurgical blunt dissectorA sterile, rigid, laparoscopic device, covered with a sheath of electrical insulation, designed to perform through a compatible laparoscopic instrument (e.g., an access port) and to be connected to an electrosurgical diathermy generator when required to provide electrical current, to facilitate blunt dissection (e.g., hernia repair, cholecystectomy, colectomy) between tissue planes accessible via the abdominal cavity. It is a monopolar device typically constructed as a long insulated metal instrument whose distal end is equipped with a stainless steel scissors-like tip of various configurations operated through scissors-like ring handles at the proximal end. 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
10607915145313GelPOINT V-PathC2B112023-03-17
10607915145320GelPOINT V-PathC2B122023-03-17
10607915145337GelPOINT V-PathC2B152023-03-17
10607915145344GelPOINT V-PathC2C112023-03-17
10607915145368GelPOINT V-PathC2C152023-03-17
10607915146693GelPOINT V-PathC2B172023-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196320516MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-05
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
10080196320493MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-04
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26