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Needle Holder Straight Ø 3 mm x 280 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref X0007218Model Senhance Surgical Instruments
Identity
- Trade Name
- Needle Holder Straight Ø 3 mm x 280 mm EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical forceps, reusable FDA UDI
- Device Name
- Needle Holder Straight FDA UDI
- Model / Reference
- Senhance Surgical Instruments EUDAMEDX0007218 EUDAMEDFDA UDI
- Description
- Needle Holder Straight FDA UDI
Identifiers
- Catalog Number
- 200-11016 FDA UDI
- Primary DI / UDI-DI
- 00815440020712 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD005UM EUDAMED
- Direct Marketing DI
- 00815440020712 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Robotic surgical forceps, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 280 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: Robotic surgical forceps, reusable
Needle Holder Straight Ø 3 mm x 280 mm by Asensus Surgical Italia S.r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Robotic surgical forceps, reusable.
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- EndoWrist — Intuitive Surgical, Inc. · Class II
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 | 081544002TD005UM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (2)
- EUDAMED 7fd3c511-5dab-4aba-b35a-77bf2e491725 61 fields · synced Jun 18, 2026
- FDA UDI b80ed30a-4ba0-4d89-a7c7-10fb2b5a8d9f 35 fields · synced May 30, 2026