FDA UDI
In Commercial Distribution
🇺🇸 United States
Arm Monopolar Maryland
DI: 03665772000084
·
Model: B-1505
·
DEX SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Arm Monopolar Maryland
- Primary DI
- 03665772000084
- Version / Model
- B-1505
- 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
- 1b3af5fe-ad9e-4498-81ee-e7bfaf341aa5
Device Description
The monopolar maryland are reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the single-use Monopolar Protection sleeve (ref. M-1304). Each Arm is composed of an insulated shaft, a connection cover and an articulated instrument that provides distal mobility 1. Tilting the tip with respect to the axis of the shaft 2. Rotation of the tip around its own axis 3. Opening-closing the tip/needle holder
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 | 03665772000084 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191878 | 000 |