FDA UDI
In Commercial Distribution
🇺🇸 United States
HandX
DI: 07290017376004
·
Model: 20-30-019-01
·
HUMAN XTENSIONS LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HandX
- Primary DI
- 07290017376004
- Version / Model
- 20-30-019-01
- Catalog Number
- 20-30-019-01
- Company Name
- HUMAN XTENSIONS LTD
- Labeler DUNS
- 600165869
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-06
- Public Version
- 1
- Public Version Date
- 2018-10-08
- Public Version Status
- New
- Public Device Record Key
- 441008c1-01fc-44ce-9ad7-80526434b0e3
Device Description
The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | 876.1500 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 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 |
|---|---|---|---|---|---|---|
| Package | 17290017376001 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 07290017376004 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 85 Percent (%) Relative Humidity