Identity
- Trade Name
- AEON EUDAMEDFDA UDI
- Generic Name
- Endoscopic manual linear cutting stapler, single-use FDA UDI
- Device Name
- AEON Endoscopic Stapler 45mm Curved Tip Reload, 4.0mm/1.8mm EUDAMEDEndoscopic Stapler 45mm Curved Tip Reload 4.0mm/1.8mm FDA UDI
- Model / Reference
- AESC45P EUDAMEDFDA UDI
- Description
- Endoscopic Stapler 45mm Curved Tip Reload 4.0mm/1.8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851574008981 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851574008981 EUDAMED
- 510(k) Number
- K171589 FDA UDI
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020301050102 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY EUDAMED
- GMDN Term
- Endoscopic manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
MR Conditional FDA UDI
Aeon by Lexington Medical, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00851574008981 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lexington Medical Inc.
- EUDAMED SRN
- US-MF-000007741
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d3ee3d1b-0ec0-45f0-8069-fb796ace3485 61 fields · synced Jun 8, 2026
- FDA UDI 0cfab6b1-ce09-4925-80d2-27fd1a983150 34 fields · synced May 27, 2026