FDA UDI
In Commercial Distribution
🇺🇸 United States
Symani NanoWrist Instruments SuperMicro Needle Holder Suture Cut
DI: 08055713171075
·
Model: INS-NeS1221
·
MEDICAL MICROINSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symani NanoWrist Instruments SuperMicro Needle Holder Suture Cut
- Primary DI
- 08055713171075
- Version / Model
- INS-NeS1221
- Company Name
- MEDICAL MICROINSTRUMENTS, INC.
- Labeler DUNS
- 435958412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-21
- Public Version
- 1
- Public Version Date
- 2025-04-29
- Public Version Status
- New
- Public Device Record Key
- 77e03303-8a63-4a1f-a231-eb201760e595
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SAQ | Electromechanical System For Open Microsurgery | General, Plastic Surgery | 878.4963 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66382 | Robotic surgical needle holder, single-use | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055713171075 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250014 | 000 |