FDA UDI
In Commercial Distribution
🇺🇸 United States
No-Splash Air-Water Syringe Tips
DI: 00723896009987
·
Model: 70-42611
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
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Basic Information
- Brand Name
- No-Splash Air-Water Syringe Tips
- Primary DI
- 00723896009987
- Version / Model
- 70-42611
- Catalog Number
- 70-42611
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- ebee35fa-618d-4bbb-9339-5153d3114be8
Device Description
an infection control shield built right in that reduces splash-back and cross contamination! The non-removable shields adjust forward or backward to accommodate varying working positions and water pressures.Does not interfere with working field or visibility Aids in cheek retraction Besides their protection value, No-Splash tips are precision-molded to deliver powerful dry air, water and mist functions without leaking. Fit all standard 3-way A-W syringes using quick change-style metal tips-no adapter required. 150 tips per dispenser box in three assorted colors.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45131 | Dental delivery system irrigation handpiece | A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896009994 | GS1 | Case | 45 | In Commercial Distribution | |
| Primary | 00723896009987 | GS1 | ||||
| Unit of Use | 00723896004074 | GS1 |