FDA UDI
In Commercial Distribution
🇺🇸 United States
Control handle
DI: 03665772000015
·
Model: P-1301
·
DEX SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Control handle
- Primary DI
- 03665772000015
- Version / Model
- P-1301
- Company Name
- DEX SURGICAL
- Labeler DUNS
- 268845728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-06
- Public Version
- 1
- Public Version Date
- 2022-05-16
- Public Version Status
- New
- Public Device Record Key
- 9fe8f5f8-d0be-4ce4-9ab7-90fd069fc1a8
Device Description
The DEX Device control handle is comprised of an ergonomic hand piece that can turn on its own axis thanks to the comfort joint. This axis can also allow the user to perform a complete manual prono-supination movement without moving his shoulder. The control handle has command buttons that activate the different degrees of freedom or the Arm. The three axes are motorized: Open/Close, Tilt (Left/Right), Rotation+/Rotation-.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58137 | Endoscopic electromechanical surgical system | An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665772000015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191878 | 000 |