Identity
- Trade Name
- Endo GIA FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- Black Radial Reload with Tri-Staple Technology FDA UDI
- Model / Reference
- EGIARADXT FDA UDI
- Description
- Black Radial Reload with Tri-Staple Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521141742 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Surgical staple loading unit, non-cutting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Surgical staple loading unit, non-cutting
Endo GIA by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical staple loading unit, non-cutting.
- Endowrist — Intuitive Surgical, Inc. · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- arcad® — NOVASTEP · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- Endowrist — Intuitive Surgical, Inc. · Class II
- ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI c3ce3b9a-f886-4eeb-9314-f5fc70b30856 35 fields · synced May 30, 2026