FDA UDI
In Commercial Distribution
🇺🇸 United States
Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe
DI: 05060548211356
·
Model: 10023
·
CMR SURGICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
96
Basic Information
- Brand Name
- Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe
- Primary DI
- 05060548211356
- Version / Model
- 10023
- Company Name
- CMR SURGICAL LIMITED
- Labeler DUNS
- 219860797
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2026-03-18
- Public Version
- 1
- Public Version Date
- 2026-03-26
- Public Version Status
- New
- Public Device Record Key
- 7c172333-ddd5-4a43-9682-f5bf53ee492a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 36152 | Electrosurgical system monitor/shield | A dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060548211356 | GS1 | ||||
| Unit of Use | 05060548211622 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252111 | 000 |