Identity
- Trade Name
- Tri-StapleTM EEATM EUDAMEDEEA FDA UDI
- Generic Name
- Intraluminal circular stapler, single-use FDA UDI
- Device Name
- EEATM Circular Stapler with Tri-StapleTM EUDAMEDBlack Circular Stapler with Tri-Staple Technology FDA UDI
- Model / Reference
- TRIEEAXL28XT EUDAMEDFDA UDI
- Description
- Black Circular Stapler with Tri-Staple Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521593138 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00012527J EUDAMED
- FDA Product Code
- GAG FDA UDIGDW FDA UDI
- EMDN Code
- H02030299 CIRCULAR STAPLERS FOR VIDEOSURGERY – OTHER EUDAMED
- GMDN Term
- Intraluminal circular stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4740 FDA UDI878.4750 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 28 Millimeter FDA UDI
Category: Intraluminal circular stapler, single-use
Eea by Covidien LP — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intraluminal circular stapler, single-use.
- Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Single Use Circular Stapler — Golden Stapler Surgical Co., Ltd · Class II
- Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Circular Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K192330 also covers:
K221005 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (2)
- FDA UDI e2096db3-56bf-46ef-8fbb-8f1a0f11b2ec 36 fields · synced Jul 20, 2026
- EUDAMED 0a8314ce-91d6-49d9-9a1d-fc5ed0df0d44 61 fields · synced Jul 20, 2026