FDA.reportPublic FDA data

EEA

Primary DI
10884523006162
Brand
EEA
Company
Covidien LP
Model
EEAXL31
Device description
Circular Stapler with DST Series Technology
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAGStapler, surgical
GDWSTAPLE, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062850000
K221003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062850000AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSUnited States Surgical, A Division of Tyco Healthc2006-10-23GDW
K221003000Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEACovidien2022-09-30GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884523006169PackageGS13In Commercial Distribution
10884523006162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452300616920884523006169
1088452300616210884523006162

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal circular stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height4.8Millimeter
Outer Diameter31Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521038967ValleylabE250510FRNSB2025-03-27
10884524002880ValleylabE250510FRNSB2025-03-27
10884521039100ValleylabE3310NSB2016-09-24
10884521141117WarmTouch50308902019-02-06
10884521205024Shiley4CN65R2016-09-24
10884521205420Shiley5CN70R2016-09-24
10884521205437Shiley6CN75R2016-09-24
10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
10884521815360NellcorMAXFAST2021-08-09
10884521815469NellcorMAXFASTI2021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255200005MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200012MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08904255200029MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909590MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909606MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909613MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909620MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909637MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909644MirusTM Linear Cutter ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909941MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909958MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909965MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909972MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
08906070909989MirusTM Linear Stapler ReloadMERIL ENDO SURGERY PRIVATE LIMITEDGDW2026-05-04
10705036040798ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10705036040811ETHICONETHICON ENDO-SURGERY, LLCGDW2025-08-22
10884521845480SigniaCovidien LPGDW2024-11-29
10884521845480SigniaCovidien LPGAG2024-11-29
10884521845497SigniaCovidien LPGAG2024-11-29
10884521845497SigniaCovidien LPGDW2024-11-29
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027850Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027867Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027874Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15
10705036027881Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
10705036027898Echelon Linear CutterETHICON ENDO-SURGERY, LLCGDW2024-04-15