Identity
- Trade Name
- UNITRAC® EUDAMEDUNITRAC FDA UDI
- Generic Name
- Surgical retraction system mounting frame, reusable FDA UDI
- Device Name
- UNITRAC holding device EUDAMEDUNITRAC Univ. Holder F. Fen. Handles, non-sterile, reusable FDA UDI
- Model / Reference
- RT071R EUDAMEDFDA UDI
- Description
- UNITRAC Univ. Holder F. Fen. Handles, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- RT071R FDA UDI
- Primary DI / UDI-DI
- 04038653082285 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000018122M EUDAMED
- Direct Marketing DI
- 04038653082285 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140101 SELF-STATIC SPREADERS, REUSABLE EUDAMED
- GMDN Term
- Surgical retraction system mounting frame, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Unitrac® by Aesculap AG — Class I — 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 | 40392390000018122M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 17fbe495-7723-4127-a3cd-b81c290cc7ae 61 fields · synced Jul 28, 2026
- FDA UDI ed7ecb56-c636-4249-8b7f-0082975bb278 35 fields · synced May 30, 2026