Identity
- Trade Name
- DUROGRIP® EUDAMEDAESCULAP FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needle holder EUDAMEDZWEIFEL DUROGRIP TC Needleholder, straight, 8", (200 mm), with 0.5 mm pitch of serration, Mathieu type handle, Mathieu type ratchetsuture up to 3/0, non-sterile, reusable FDA UDI
- Model / Reference
- BM170R EUDAMEDFDA UDI
- Description
- ZWEIFEL DUROGRIP TC Needleholder, straight, 8", (200 mm), with 0.5 mm pitch of serration, Mathieu type handle, Mathieu type ratchetsuture up to 3/0, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BM170R FDA UDI
- Primary DI / UDI-DI
- 04038653139729 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000038128 EUDAMED
- Direct Marketing DI
- 04038653139729 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
Durogrip® 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 a67b8e46-08a4-49aa-b6e8-48e97d403f50 61 fields · synced Jun 19, 2026
- FDA UDI f25b2768-f198-428c-bb9f-31938464e1ce 35 fields · synced May 30, 2026