FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pentax irrigation pump
DI: 00677964085536
·
Model: EGA-500P
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pentax irrigation pump
- Primary DI
- 00677964085536
- Version / Model
- EGA-500P
- Catalog Number
- EGA500P
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 6
- Public Version Date
- 2023-04-27
- Public Version Status
- Update
- Public Device Record Key
- d292c238-e399-424a-8a55-6570913ac6b5
- Distribution End Date
- 2023-04-25
Device Description
PENTAX Irrigation Endo 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
- 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 |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33579 | Surgical irrigation/aspiration pump, reusable | An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30677964085537 | GS1 | Case | 1 | Not in Commercial Distribution | 2023-04-25 |
| Primary | 00677964085536 | GS1 |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113119 | 000 |