FDA.reportPublic FDA data

easyEndoTM Lite Linear Cutting Stapler for Single Use

Primary DI
06925776102595
Brand
easyEndoTM Lite Linear Cutting Stapler for Single Use
Company
Ezisurg Medical Co., Ltd.
Model
U12L45
Catalog number
U12L45
Device description
Lite Linear Cutting Stapler, 440mm long, 12.3mm diameter
Published
2021-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
16925776102592PackageGS11In Commercial Distribution
76925776102594PackageGS13In Commercial Distribution
06925776102595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692577610259216925776102592
7692577610259476925776102594
06925776102595069257761025956925776102595

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic manual linear cutting stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
421348845
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925776119319easyLCTM Linear Cutter Staplers and Loading Units for Single UseLCC60BLCC60B2026-02-04
66925776119311easyLCTM Linear Cutter Staplers and Loading Units for Single UseLCC60BLCC60B2026-02-04
06925776102458easyEndoTM Lite Loading Unit for Single UseN45WN45W2021-08-08
06925776102465easyEndoTM Lite Loading Unit for Single UseN45BN45B2021-08-08
06925776102472easyEndoTM Lite Loading Unit for Single UseN45CN45C2021-08-10
06925776102489easyEndoTM Lite Loading Unit for Single UseN45GN45G2021-08-10
06925776102496easyEndoTM Lite Loading Unit for Single UseN60MN60M2021-08-10
06925776102502easyEndoTM Lite Loading Unit for Single UseN60WN60W2021-08-10
06925776102519easyEndoTM Lite Loading Unit for Single UseN60BN60B2021-08-10
06925776102526easyEndoTM Lite Loading Unit for Single UseN60CN60C2021-08-10
06925776102533easyEndoTM Lite Loading Unit for Single UseN60GN60G2021-08-08
06925776102571easyEndoTM Lite Linear Cutting Stapler for Single UseU12S45U12S452021-08-08
06925776102588easyEndoTM Lite Linear Cutting Stapler for Single UseU12M45U12M452021-08-10
06925776102601easyEndoTM Lite Linear Cutting Stapler for Single UseU12S60U12S602021-08-10
06925776102618easyEndoTM Lite Linear Cutting Stapler for Single UseU12M60U12M602021-08-10
06925776112570easyCSTM Circular Stapler for Single UseCS2135CS21352025-01-07
06925776112587easyCSTM Circular Stapler for Single UseCS2148CS21482025-01-07
06925776112594easyCSTM Circular Stapler for Single UseCS2535CS25352025-01-07
06925776112600easyCSTM Circular Stapler for Single UseCS2548CS25482025-01-07
06925776112617easyCSTM Circular Stapler for Single UseCS2935CS29352025-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000378TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27