Identity
- Trade Name
- JESCO EUDAMEDFDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Impression Tray EUDAMEDIMPRESSION TRAY F.LOWER JAW UB 4 FDA UDI
- Model / Reference
- DR084R EUDAMEDFDA UDI
- Description
- IMPRESSION TRAY F.LOWER JAW UB 4 FDA UDI
Identifiers
- Catalog Number
- DR084R FDA UDI
- Primary DI / UDI-DI
- 04038653149384 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000043ZE EUDAMED
- Direct Marketing DI
- 04038653149384 EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- L1504 ODONTOSTOMATOLOGY MODELERS, REUSABLE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 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
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
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
Jesco 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 | 4039239000000043ZE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED f02d8c3c-0200-4e21-9d95-604ac9b5f9a9 61 fields · synced Aug 3, 2026
- FDA UDI 1d8d945a-4bdd-4ef9-a83c-0ff05511787f 35 fields · synced May 30, 2026