Identity
- Trade Name
- Tri-Staple 2.0 FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- Black Reinforced Intelligent Reload, For use with Signia stapling system FDA UDI
- Model / Reference
- SIGTRSB60AXT FDA UDI
- Description
- Black Reinforced Intelligent Reload, For use with Signia stapling system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521717633 FDA UDI
- 510(k) Number
- K173270 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
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Surgical staple loading unit, non-cutting
Tri-Staple 2.0 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.
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- arcad® — NOVASTEP · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- Endowrist — Intuitive Surgical, Inc. · Class II
- ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
Cleared under the same submission
K173270 also covers:
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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 97c1fe09-d703-4d5f-b5a3-5112ddafe8b2 37 fields · synced May 30, 2026