FDA.reportPublic FDA data

EEA

Primary DI
20884521827636
Brand
EEA
Company
Covidien LP
Model
TRIEEAXL21MTORVIL
Device description
CIR STPLR TRIEEAXL21MT wTRISTP nORVL
Published
2025-02-07
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
K232126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232126000EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilCovidien2023-08-16GAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521827636PackageGS13In Commercial Distribution
10884521827639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182763620884521827636
1088452182763910884521827639

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
Outer Diameter21Millimeter

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
true
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
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521703827Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGAG2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGAG2026-07-31
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000378TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27