Identity
- Trade Name
- ENDOPATH DEXTRUS EUDAMEDFDA UDI
- Generic Name
- Radial surgical retractor FDA UDI
- Device Name
- ENDOPATH DEXTRUS Fixed-Length Retractors EUDAMEDEndopath Dextrus Fixed-Length Access Retractors Small (up to 4cm abdominal thickness) FDA UDI
- Model / Reference
- FLR01 EUDAMEDFDA UDI
- Description
- Endopath Dextrus Fixed-Length Access Retractors Small (up to 4cm abdominal thickness) FDA UDI
Identifiers
- Catalog Number
- FLR01 FDA UDI
- Primary DI / UDI-DI
- 10705036001966 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000536T EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
- GMDN Term
- Radial surgical retractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
No
FDA UDI
Endopath Dextrus by Ethicon Endo-Surgery, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000536T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 6e24266a-6366-4296-807d-9bc7fa87f92d 61 fields · synced Jul 25, 2026
- FDA UDI 8fa6c96f-fec1-4365-a6be-11c87ad6b415 35 fields · synced May 29, 2026