Identity
- Trade Name
- Reliamax FDA UDI
- Generic Name
- Open-surgery manual linear stapler, reusable FDA UDI
- Device Name
- Reusable Gastrointestinal Anastomosis Stapler FDA UDI
- Model / Reference
- GIA60RS FDA UDI
- Description
- Reusable Gastrointestinal Anastomosis Stapler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521174894 FDA UDI
- 510(k) Number
- K122781 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Open-surgery manual linear stapler, reusable 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Open-surgery manual linear stapler, reusable
Reliamax by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery manual linear stapler, reusable.
- Reliamax — Covidien LP · Class II
- TA Premium — Covidien LP · Class I
- TA Premium — Covidien LP · Class I
- GIA Premium — Covidien LP · Class I
- Endo GIA — Covidien LP · Class II
- Endo GIA — Covidien LP · Class II
- TA Premium — Covidien LP · Class I
Cleared under the same submission
K122781 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI c95a8ba8-67ec-4dfd-bd98-3b8fbe44ecff 36 fields · synced May 31, 2026