FDA.reportPublic FDA data

easyEndoTM E-Lite Single Use Cartridges

Primary DI
06925776106050
Brand
easyEndoTM E-Lite Single Use Cartridges
Company
Ezisurg Medical Co., Ltd.
Model
PN60M
Catalog number
PN60M
Device description
Single Use Cartridge, Gray, 60mm, 2.0mm
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254291000easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.2026-09-25GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
66925776106052PackageGS112In Commercial Distribution
76925776106059PackageGS14In Commercial Distribution
06925776106050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6692577610605266925776106052
7692577610605976925776106059
06925776106050069257761060506925776106050

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, non-cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
421348845
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925776106067easyEndoTM E-Lite Single Use CartridgesPN60WPN60W2026-10-21
06925776106074easyEndoTM E-Lite Single Use CartridgesPN60BPN60B2026-10-21
06925776106081easyEndoTM E-Lite Single Use CartridgesPN60CPN60C2026-10-21
06925776106098easyEndoTM E-Lite Single Use CartridgesPN60GPN60G2026-10-21
06925776106104easyEndoTM E-Lite Single Use CartridgesPN45MPN45M2026-10-21
06925776106111easyEndoTM E-Lite Single Use CartridgesPN45WPN45W2026-10-21
06925776106128easyEndoTM E-Lite Single Use CartridgesPN45BPN45B2026-10-21
06925776106135easyEndoTM E-Lite Single Use CartridgesPN45CPN45C2026-10-21
06925776106142easyEndoTM E-Lite Single Use CartridgesPN45GPN45G2026-10-21
06925776121923easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UL45P2UL452026-10-21
06925776121930easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UL45GP2UL45G2026-10-21
06925776121947easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UL60P2UL602026-10-21
06925776121954easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UL60GP2UL60G2026-10-21
06925776121961easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UM45P2UM452026-10-21
06925776121978easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UM45GP2UM45G2026-10-21
06925776121985easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UM60P2UM602026-10-21
06925776121992easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UM60GP2UM60G2026-10-21
06925776122005easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2US45P2US452026-10-21
06925776122012easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2US45GP2US45G2026-10-21
06925776122029easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2US60P2US602026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925776106067easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106074easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106081easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106098easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106104easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106111easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106128easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106135easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106142easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000439TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27