Micro Needle Holder Suture Cut
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Micro Needle Holder Suture Cut EUDAMEDSymani NanoWrist Instruments Micro Needle Holder Suture Cut FDA UDI
- Generic Name
- Robotic surgical needle holder, single-use FDA UDI
- Device Name
- Symani NanoWrist Instrument EUDAMEDA surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device. FDA UDI
- Model / Reference
- INS-AaT2221 EUDAMEDINS-AeT2221 EUDAMEDINS-AeT1221 FDA UDI
- Description
- A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055713171037 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571317SymNWWA EUDAMED
- FDA Product Code
- SAQ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Robotic surgical needle holder, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4963 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Micro Needle Holder Suture Cut by Medical Microinstruments, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805571317SymNWWA | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medical Microinstruments, Inc.
- EUDAMED SRN
- IT-MF-000013306
Sources (2)
- EUDAMED 10b40f3a-3872-499f-9755-e79d66489a37 61 fields · synced Jun 19, 2026
- FDA UDI 29057308-9997-4003-a90f-bbcdba8fd7c6 33 fields · synced May 30, 2026