FDA.reportPublic FDA data

MicroCutter 30 Blue Reload

Primary DI
11814900003209
Brand
MicroCutter 30 Blue Reload
Company
AESDEX, LLC
Model
FG-025320
Catalog number
FG-025320
Device description
MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K161137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161137000Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.2016-07-20GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
11814900003209PrimaryGS10
01814900003202Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1181490000320911814900003209
01814900003202018149000032021814900003202

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081132841
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
11814900000031Cardica Vein/Aorta GaugeFG-000003FG-0000032019-02-19
11814900003100MicroCutter 30 White ReloadFG-025310FG-0253102016-08-08
11814900003117MicroCutter 30 Curved Tip White ReloadFG-025311FG-0253112016-08-08
11814900003216MicroCutter 30 Curved Tip Blue ReloadFG-025321FG-0253212016-08-08
11814900000017Cardica PAS-Port Proximal Anastomosis SystemFG-000001FG-0000012016-08-08
11814900001007Cardica C-Port xA Plus Anastomosis SystemFG-000100FG-0001002016-08-08
11814900001502Cardica C-Port Flex-A Plus Distal Anastomosis SystemFG-000150FG-0001502016-08-08
11814900003025Dextera MicroCutter 5/80 StaplerFG-025302FG-0253022016-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16953886000446TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000453TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000460TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000477TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000484TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000491TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000514TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000521TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000569TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001429TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001443TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001450TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886001467TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27