Identity
- Trade Name
- ADTEC EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- AdTec needle holder EUDAMEDADTEC TC Needleholder complete instrument, straight, (370 mm), diam. 5 mm, non-sterile, reusable FDA UDI
- Model / Reference
- PL404R EUDAMEDFDA UDI
- Description
- ADTEC TC Needleholder complete instrument, straight, (370 mm), diam. 5 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- PL404R FDA UDI
- Primary DI / UDI-DI
- 04038653364183 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000002992N EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L1205 LAPAROSCOPIC AND THORACOSCOPIC SURGERY NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Adtec 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 | 40392390000002992N | 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 2c83a472-0af4-4a94-ba25-86522f61d3bd 61 fields · synced Jun 18, 2026
- FDA UDI 87e63676-d117-4bcb-82d5-38dbeb144fb1 35 fields · synced May 30, 2026