FDA UDI
In Commercial Distribution
🇺🇸 United States
Set of hoses 2 for NaCl pump
DI: EFID66259530
·
Model: 6625953
·
SIRONA Dental Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Set of hoses 2 for NaCl pump
- Primary DI
- EFID66259530
- Version / Model
- 6625953
- Catalog Number
- 6625953
- Company Name
- SIRONA Dental Systems GmbH
- Labeler DUNS
- 340306351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-05-15
- Public Version
- 1
- Public Version Date
- 2023-05-23
- Public Version Status
- New
- Public Device Record Key
- 24ccd541-6cf8-419c-9955-914d810ca8dd
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EFS | UNIT, ORAL IRRIGATION | Dental | 872.6510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47890 | Disposable surgical irrigation/aspiration system | A device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EFID66259610 | HIBCC | ||||
| Primary | EFID66259530 | HIBCC |