Identity
- Trade Name
- easyEndoTM Lite Loading Unit for Single Use FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Lite Loading Unit, 45mm long, staple height 3.8mm, gold FDA UDI
- Model / Reference
- N45C FDA UDI
- Description
- Lite Loading Unit, 45mm long, staple height 3.8mm, gold FDA UDI
Identifiers
- Catalog Number
- N45C FDA UDI
- Primary DI / UDI-DI
- 06925776102472 FDA UDI
- 510(k) Number
- K210909 FDA UDI
- FDA Product Code
- GDW FDA UDI
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use 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
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Endoscopic manual linear cutting stapler, single-use
easyEndoTM Lite Loading Unit for Single Use by Ezisurg Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic manual linear cutting stapler, single-use.
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- 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
- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K210909 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
- Ezisurg Medical Co., Ltd.
Sources (1)
- FDA UDI cea1d96e-0796-4729-8db3-b1c3c115982a 36 fields · synced Jun 8, 2026