Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, tweezers-like, reusable FDA UDI
- Device Name
- ENT forceps I EUDAMEDQUIRE Foreign Body Removal Instrumen, 3 1/2", (90 mm) FDA UDI
- Model / Reference
- OF300R EUDAMEDFDA UDI
- Description
- QUIRE Foreign Body Removal Instrumen, 3 1/2", (90 mm) FDA UDI
Identifiers
- Catalog Number
- OF300R FDA UDI
- Primary DI / UDI-DI
- 04038653176311 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000001224ZT EUDAMED
- Direct Marketing DI
- 04038653176311 EUDAMED
- FDA Product Code
- KAE FDA UDI
- EMDN Code
- L03130402 FORCEPS FOR EXTERNAL BODIES, REUSABLE EUDAMED
- GMDN Term
- Surgical soft-tissue manipulation forceps, tweezers-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
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
Category: Bronchoscopic biopsy curette, rigid
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Bronchoscopic biopsy curette, rigid.
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- Belux Surgical Instruments — Belux Surgical Instruments · 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 | 4039239000001224ZT | 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 5ab79da3-b8f7-4ace-bb86-5bc7acf7db11 61 fields · synced Jul 20, 2026
- FDA UDI 143615e5-0148-4bdf-8ea5-e058b5b93cf5 36 fields · synced May 30, 2026