FDA.reportPublic FDA data

easyEndoTM Lite Linear Cutting Stapler for Single Use

Primary DI
16925776102578
Brand
easyEndoTM Lite Linear Cutting Stapler for Single Use
Company
Ezisurg Medical Co., Ltd.
Model
U12S45
Catalog number
U12S45
Device description
Lite Linear Cutting Stapler, 260mm long, 12.3mm diameter
Published
2021-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAGStapler, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210909000easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.2021-06-24GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16925776102578PackageGS11In Commercial Distribution
76925776102570PackageGS13In Commercial Distribution
06925776102571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692577610257816925776102578
7692577610257076925776102570
06925776102571069257761025716925776102571

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
true
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
06925776121404easyEndoTM E-Lite Single Use CartridgesPN45TPN45T2026-10-26
06925776121428easyEndoTM E-Lite Single Use CartridgesPN60TPN60T2026-10-26
06925776106050easyEndoTM E-Lite Single Use CartridgesPN60MPN60M2026-10-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925776121923easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121930easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121947easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121954easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121961easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121978easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121985easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776121992easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122005easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122012easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122029easyEndoTM E-Lite Single Use Powered Endoscopic StaplersEzisurg Medical Co., Ltd.GAG2026-10-21
06925776122036easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipEzisurg Medical Co., Ltd.GAG2026-10-21
00190776431129MillenniumAvalign Technologies, Inc.GAG2026-09-21
10884521703827Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGAG2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGAG2026-07-31
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27