FDA.reportPublic FDA data

Tri-Staple 2.0

Primary DI
20884521703770
Brand
Tri-Staple 2.0
Company
Covidien LP
Model
SIGCIR33XT
Device description
Black Extra Thick Circular Reload For use with Signia Circular Adapters
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K221629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221629000Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)Covidien2023-02-22GAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521703770PackageGS16In Commercial Distribution
10884521703773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452170377020884521703770
1088452170377310884521703773

GMDN Terms#

Term, Definition table
TermDefinition
Surgical staple loading unit, cuttingA unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) and an internal cutting blade designed to be used with a surgical stapler (not included) during endoscopic or open-surgery (e.g., bowel resection to create anastomoses). The unit is designed to deploy the staples (e.g., in a straight or circular row) while the blade cuts the adjacent tissue. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter33Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature63 Degrees Fahrenheit94 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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
false
Expiration date on label
false
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
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479282852McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282883McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282890McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282906McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282913McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282920McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282937McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479282944McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283019McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283194McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283200McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283217McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283224McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283231McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283248McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479283255McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284597McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284641McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479284986McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285006McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285020McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
20612479285105McKessonMCKESSON MEDICAL-SURGICAL INC.GAG2026-05-26
00190776409500MillenniumAvalign Technologies, Inc.GAG2025-09-02
10705036043522ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043539ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10705036043546ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043529ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043536ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
10888277368293MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14