FDA.report

ECHELON Flex ENDOPATH

Primary DI
20705036014376
Brand
ECHELON Flex ENDOPATH
Company
ETHICON ENDO-SURGERY, LLC
Model
PLE45A
Catalog number
PLE45A
Device description
Echelon Flex45 Powered Endopath Stapler Long Articulating Endoscopic Linear Cutter
Published
2015-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDWSTAPLE, IMPLANTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20705036014376PrimaryGS10
10705036014379Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2070503601437620705036014376
1070503601437910705036014379

GMDN Terms

TermDefinition
Endoscopic motorized cutting stapler, single-useA sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses; it may also be used during open surgery. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor in the handle. This device is typically loaded with staples and may be pistol-like in design. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags

DUNS number
044606982
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20705036043543ETHICONEC3D60LEC3D60L2025-08-22
30705036039284DUALTO Energy SystemETHOVKETHOVK2025-06-20
30705036038362DUALTO Energy SystemETHCMETHCM2025-06-18
30705036038379DUALTO Energy SystemETHUSCETHUSC2025-06-18
30705036038386DUALTO Energy SystemETHEMETHEM2025-06-18
30705036038393DUALTO Energy SystemETHEF2ETHEF22025-06-18
30705036038409DUALTO Energy SystemETHEF1ETHEF12025-06-18
30705036038416DUALTO Energy SystemETHERFETHERF2025-06-18
30705036038423DUALTO Energy SystemETHCRTETHCRT2025-06-18
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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06946480503638Disposable Linear Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480510537Disposable Curved Cutter Staplers Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480563632Disposable Linear Staplers and ReloadsSinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576052Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480576151Disposable Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589311Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589366Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
06946480589373Disposable Endoscopic Linear Cutter Staplers and Reloads Sinolinks Medical Innovation Co., Ltd.GDW2025-09-04
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20705036040856ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
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