FDA UDI
In Commercial Distribution
🇺🇸 United States
Dexter Monopolar Scissors
DI: 07640184840479
·
Model: Dexter L6
·
Distalmotion SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dexter Monopolar Scissors
- Primary DI
- 07640184840479
- Version / Model
- Dexter L6
- Catalog Number
- 707
- Company Name
- Distalmotion SA
- Labeler DUNS
- 486345080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-24
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 2979b901-9f5f-40c3-8e43-10706437eab1
Device Description
Dexter L6 Monopolar Scissors
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| SDD | Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field | General, Plastic Surgery | 878.4965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38678 | Robotic surgical telemanipulation system | An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07640184840486 | GS1 | Carboard box | 4 | In Commercial Distribution | |
| Primary | 07640184840479 | GS1 |
Customer Contacts
- Phone
- 216-744-2602
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN230084 | 000 |