Identity
- Trade Name
- DUROGRIP® EUDAMEDAESCULAP FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needle holder EUDAMEDJACOBSON DUROGRIP TC Micro Needle Holder, straight, 8", (200 mm), round handle, with ratchet, non-sterile, reusable FDA UDI
- Model / Reference
- MB213R EUDAMEDFDA UDI
- Description
- JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8", (200 mm), round handle, with ratchet, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- MB213R FDA UDI
- Primary DI / UDI-DI
- 04038653411153 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000038128 EUDAMED
- Direct Marketing DI
- 04038653411153 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 2b8f033b-f3c2-4493-822e-ca991834000e 61 fields · synced Jun 18, 2026
- FDA UDI eb7136b2-a5fc-499f-89f7-43c8c67d5cc3 35 fields · synced May 30, 2026