Identity
- Trade Name
- GIA Premium FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Loading Unit FDA UDI
- Model / Reference
- 030424L FDA UDI
- Description
- Loading Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884523007091 FDA UDI
- 510(k) Number
- K801590 FDA UDI
- FDA Product Code
- FHM FDA UDI
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIHeight — 3.8 Millimeter FDA UDI
Category: Endoscopic manual linear cutting stapler, single-use
GIA Premium by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic manual linear cutting stapler, single-use.
- ECHELON ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · Class II
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- Titan SGS Standard Gastric Stapler — Standard Bariatrics · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
- ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K801590 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 4673e260-89f2-4acf-8a8a-15b6ecfbb24c 37 fields · synced May 30, 2026