Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Dressing/utility forceps, scissors-like, reusable FDA UDI
- Device Name
- ENT forceps Ir EUDAMEDHARTMANN Ear Tampon Forceps, straight, 5", (135 mm), heavy pattern, knee bent, non-sterile, reusable FDA UDI
- Model / Reference
- OF405R EUDAMEDFDA UDI
- Description
- HARTMANN Ear Tampon Forceps, straight, 5", (135 mm), heavy pattern, knee bent, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- OF405R FDA UDI
- Primary DI / UDI-DI
- 04038653051328 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000001225ZV EUDAMED
- Direct Marketing DI
- 04038653051328 EUDAMED
- FDA Product Code
- KAE FDA UDI
- EMDN Code
- L031302 MEDICATION FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Dressing/utility forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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
Yes
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
Category: Dressing/utility forceps, tweezers-like, reusable
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dressing/utility forceps, tweezers-like, reusable.
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Symmetry Willauer-Allis — SYMMETRY SURGICAL INC. · Class I
- Symmetry Duval — SYMMETRY SURGICAL INC. · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- Anmuth Medical International — ANMUTH MEDICAL INTERNATIONAL LLC · Class I
- Symmetry Babcock — SYMMETRY SURGICAL INC. · Class I
- Sklar — Sklar Corporation · Class I
- Reicodent — devemed GmbH · Class I
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 | 4039239000001225ZV | 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 6d7cc733-eb1e-4a6f-8711-4e71d64afeb5 61 fields · synced May 30, 2026
- FDA UDI 1038c393-595e-4aad-9c5c-e9cdc3619949 35 fields · synced May 30, 2026