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 EUDAMEDCircular Stapler with Tri-Staple Technology FDA UDI
- Model / Reference
- TRIEEAXL28MT EUDAMEDFDA UDI
- Description
- Circular Stapler with Tri-Staple Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521593121 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00012527J EUDAMED
- FDA Product Code
- GDW FDA UDIGAG 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
- 878.4750 FDA UDI878.4740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 cfd4265f-7b81-44c3-96c2-a6849e76fefc 35 fields · synced Jun 19, 2026
- EUDAMED 1887913c-9260-4bf2-91b8-7f89ae0d4cb9 61 fields · synced Jun 19, 2026