Hydrodebrider
- Primary DI
- 00763000548803
- Company
- MEDTRONIC XOMED, INC.
- Model
- 1921002
- Device description
- HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS
- Published
- 2026-02-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 835465063
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000548803 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00763000548803 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| KMA | Irrigator, Powered Nasal | 1 | Ear, Nose, Throat | 874.5550 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Nasal lavage system | A device assembly designed for automated or semi-automated irrigation and washing of tissue and/or debris from the nose and/or the nasal sinuses. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the nostrils. The system is used mainly for allergy treatment, nasal congestion, and before and after surgery. |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
| Phone | Email |
|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
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