FDA UDI
In Commercial Distribution
🇺🇸 United States
DEFENDO Biopsy Valve Irrigator
DI: 00724995246716
·
Model: 100303
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- DEFENDO Biopsy Valve Irrigator
- Primary DI
- 00724995246716
- Version / Model
- 100303
- Catalog Number
- 100303
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-06
- Public Version
- 1
- Public Version Date
- 2026-04-14
- Public Version Status
- New
- Public Device Record Key
- 90f52081-d0c2-472f-99a6-d35fde0ea43a
Device Description
DEFENDO Biopsy Valve Irrigator Y-OPSY Valve for Olympus and Fujifilm GI Endoscopes
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope channel accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60760 | Endoscope channel support kit | A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50724995246711 | GS1 | Case | 5 | In Commercial Distribution | |
| Package | 10724995246713 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00724995246716 | GS1 | ||||
| Previous | 00677964060281 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110088 | 000 |