Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needle holder EUDAMEDADSON Needleholder, straight, 7", (180 mm), longitudinal opening in 1 jaw, non-sterile, reusable FDA UDI
- Model / Reference
- BM224R EUDAMEDFDA UDI
- Description
- ADSON Needleholder, straight, 7", (180 mm), longitudinal opening in 1 jaw, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BM224R FDA UDI
- Primary DI / UDI-DI
- 04038653028764 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000038128 EUDAMED
- Direct Marketing DI
- 04038653028764 EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L0205 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
Category: Suturing needle holder, reusable
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 403923900000038128 | 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 87e6e3ba-e188-4857-bc95-fee0347f27a6 61 fields · synced Jul 14, 2026
- FDA UDI f217433a-1c25-4634-9288-543825fbb3de 35 fields · synced May 30, 2026