FDA UDI
In Commercial Distribution
🇺🇸 United States
IRRIGATOR/INSUFFLATOR
DI: 04961333242924
·
Model: EGA-500P
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IRRIGATOR/INSUFFLATOR
- Primary DI
- 04961333242924
- Version / Model
- EGA-500P
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-12
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- ebb6d521-f814-407d-a554-e1cd25ad1e70
Device Description
PENTAX MEDICAL IRRIGATION PUMP
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
- No
- 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 |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47800 | Surgical fluid/gas irrigator | A sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333242924 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113119 | 000 |