FDA.reportPublic FDA data

MaxTack

Primary DI
10884521826267
Brand
MaxTack
Company
Covidien LP
Model
MAXTACK30
Device description
Motorized Fixation Device 30 Absorbable Tacks
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDWStaple, implantable
OCWEndoscopic tissue approximation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231240000MaxTack™ Motorized Fixation DeviceCovidien2023-09-08OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521826264PackageGS16In Commercial Distribution
10884521826267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182626420884521826264
1088452182626710884521826267

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue repair material fixation tackAn implantable bioabsorbable device intended to be used for the fixation of soft-tissue repair material (e.g., prosthetic silicone sheet, surgical mesh) during surgical repair and reconstruction of soft-tissue defects (e.g., ventral and groin hernia). It is not designed for dental or ophthalmic applications. It is in the form of a small cylinder with a rounded head and a tapered end made of synthetic polymer materials; it is available independently or preloaded in a disposable implantation device (e.g., motorized handpiece).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit118 Degrees Fahrenheit
Storage Environment Atmospheric Pressure55 KiloPascal101 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit118 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
10884521853829Shiley1108652026-10-25
10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02
10884521546349Surgipro IIVP86X2016-09-24
10884521701991MonosofCN793G2017-10-10
10884521702073Surgipro IIVP746XG2017-10-10
10884521702172SurgiproCP41G2017-10-10
10884521705173SurgiproSP690G2017-06-23
10884521171534Nellcor10005941-SG2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16953886000415TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000422TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27