FDA UDI
In Commercial Distribution
🇺🇸 United States
Versius Fenestrated Grasper
DI: 05060548211271
·
Model: 10320
·
CMR SURGICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Versius Fenestrated Grasper
- Primary DI
- 05060548211271
- Version / Model
- 10320
- Company Name
- CMR SURGICAL LIMITED
- Labeler DUNS
- 219860797
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-09
- Public Version
- 1
- Public Version Date
- 2026-03-17
- Public Version Status
- New
- Public Device Record Key
- 5d1eb619-666d-45aa-979e-b05fa36b3953
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SCV | Modular Electromechanical Surgical System | General, Plastic Surgery | 878.4964 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63113 | Robotic surgical forceps, reusable | A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060548211271 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252111 | 000 |