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easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PU12M
Identity
- Trade Name
- easyEndo™ UniPlus Single Use Powered Endoscopic Stapler EUDAMEDeasyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use FDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- Single Use Powered Endoscopic Staplers EUDAMEDLoading Units, 30±2mm Long, 2.5±0.2mm height, white FDA UDI
- Model / Reference
- PU12M EUDAMEDL30W FDA UDI
- Description
- Loading Units, 30±2mm Long, 2.5±0.2mm height, white FDA UDI
Identifiers
- Catalog Number
- L30W FDA UDI
- Primary DI / UDI-DI
- 06925776123552 EUDAMEDFDA UDI
- Basic UDI-DI
- 69257761002501Y3 EUDAMED
- 510(k) Number
- K172960 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201020202,H020301050201,H020301050202 EUDAMED
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Universal Linear Cutting Stapler and Loading Units for Single Use by Ezisurg Medical Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID…
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Also classified as Endoscopic manual linear cutting stapler, single-use.
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- ENDOPATH — ETHICON ENDO-SURGERY, INC. · Class II
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- Reloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd. · Class II
Cleared under the same submission
K172960 also covers:
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
- easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd.
Sources (2)
- FDA UDI 21166868-2bda-43c1-bcd5-628088977f37 36 fields · synced Jun 19, 2026
- EUDAMED 02e6fcd3-da39-4d58-8c5b-feba1704ed9a 61 fields · synced Jun 19, 2026