FDA.reportPublic FDA data

MirusTM Linear Stapler Reload

Primary DI
08904255200005
Brand
MirusTM Linear Stapler Reload
Company
MERIL ENDO SURGERY PRIVATE LIMITED
Model
MLSR60-4.8
Device description
Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus Linear stapler are supplied separately.
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K200320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200320000Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and ReloadM/s. Meril Endo Surgery Private Limited.2021-02-05GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904255200005PrimaryGS10
18904255200002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904255200005089042552000058904255200005
1890425520000218904255200002

Regulatory Flags#

DUNS number
870914838
Device count
6
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
08904255243903PINION™ PDO Knotless SuturePNDS0102012026-05-05
08904255244009PINION™ PDO Knotless SuturePNDS0103072026-05-05
08904255244016PINION™ PDO Knotless SuturePNDS0103172026-05-05
08904255247628PINION™ PDO Knotless SuturePNDS0104042026-05-05
08904255247697PINION™ PDO Knotless SuturePNDS4006032026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suPNDS010201H2026-05-05
08904255250925PINION™ PDO Knotless SuturePNDS010201XL2026-05-05
08904255251021PINION™ PDO Knotless SuturePNDS0104002026-05-05
08904255251168PINION™ PDO Knotless SuturePNDS10202BD2026-05-05
08904255252141PINION™ PDO Knotless SuturePNDS01405BD2026-05-05
08904255252158PINION™ PDO Knotless SuturePNDS0104052026-05-05
08904255252301PINION™ PDO Knotless SuturePNDS0102032026-05-05
08904255252318PINION™ PDO Knotless SuturePNDS0102052026-05-05
08904255252332PINION™ PDO Knotless SuturePNDS0104432026-05-05
08904255252349PINION™ PGA-PCL Knotless SuturePNDS0104452026-05-05
08904255252370PINION™ PDO Knotless SuturePNDS0104442026-05-05
08904255252820PINION™ PDO Knotless SuturePNDS4001202026-05-05
08904255253049PINION™ PDO Knotless SuturePNDS4004542026-05-05
08904255256422PINION™ PDO Knotless SuturePNDS010205H2026-05-05
08904255256637PINION™ PDO Knotless SuturePNDS010201XLH2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925776121404easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776121428easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776106050easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
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