FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe-Tips EZ
DI: 00615375003695
·
Model: 44150C
·
METREX RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
Basic Information
- Brand Name
- Safe-Tips EZ
- Primary DI
- 00615375003695
- Version / Model
- 44150C
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 763a3b66-3421-4105-a1d3-bd8fb9bc420d
Device Description
Disposable AirWater Syringe Tip Interchangeable with Most Metal Tips
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIA | UNIT, OPERATIVE DENTAL | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35970 | Dental irrigation/aspiration syringe | A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | D6834415010 | HIBCC | ||||
| Primary | 00615375003695 | GS1 | ||||
| Unit of Use | 00615375006788 | GS1 |
Customer Contacts
- Phone
- +18008411428
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951238 | 000 |