FDA UDI
In Commercial Distribution
🇺🇸 United States
Endogator Kit
DI: 40677964028104
·
Model: 4005471
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Endogator Kit
- Primary DI
- 40677964028104
- Version / Model
- 4005471
- Catalog Number
- 4005471
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-14
- Public Version
- 1
- Public Version Date
- 2022-07-22
- Public Version Status
- New
- Public Device Record Key
- 9f24d90a-e088-4385-9be4-1cef1ecd969e
Device Description
Endogator Kit includes Endogator Irrigation Tubing compatible with Boston Scientific Endostat II, Olympus OFP and Endo Stratus Irrigation Pump units, and Endo ENDO SMARTCAP Rinse and insufflation Tubing for PENTAX GI Endoscopes.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 46102 | Surgical irrigation tubing set, single-use | A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40677964028111 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 40677964028104 | GS1 | ||||
| Package | 40677964028128 | GS1 | Case | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)444-4729
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102855 | 000 |