FDA UDI
In Commercial Distribution
🇺🇸 United States
Scissors
DI: 08055713171082
·
Model: INS-RfM3220
·
MEDICAL MICROINSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scissors
- Primary DI
- 08055713171082
- Version / Model
- INS-RfM3220
- Company Name
- MEDICAL MICROINSTRUMENTS, INC.
- Labeler DUNS
- 435958412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-06
- Public Version
- 1
- Public Version Date
- 2026-03-16
- Public Version Status
- New
- Public Device Record Key
- e9f702a8-3e2b-48b2-94e9-c97004d127fa
Device Description
A surgical device intended to be used in conjunction with a robotic surgical system to cut tissue or sutures during a robotic open-surgical procedure. It is designed as a long shaft with a pair of mechanical (i.e., not electrosurgical) cutting blades at the distal end, 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
- Yes
- 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 |
|---|---|---|---|---|
| 67598 | Robotic surgical scissors, open-surgery | A surgical device intended to be used in conjunction with a robotic surgical system to cut tissue or sutures during a robotic open-surgical procedure. It is designed as a long shaft with a pair of mechanical (i.e., not electrosurgical) cutting blades at the distal end, 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 | 08055713171082 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252287 | 000 |