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 EUDAMEDCellular Stapler with Tri-Staple Technology FDA UDI
- Model / Reference
- TRIEEA31MT EUDAMEDFDA UDI
- Description
- Cellular Stapler with Tri-Staple Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521593046 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
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 — 31 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
K172361 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 8ba141f7-ce69-4b3c-89d0-e4f33ba1b0f1 36 fields · synced Jul 25, 2026
- EUDAMED a4fd467e-871a-4c2d-8fb7-3b7f681615bd 61 fields · synced Jul 25, 2026