FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPRESS-RITE HP MIXING TIPS
DI: 00818524020493
·
Model: VPS-8104
·
CROWN DELTA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- IMPRESS-RITE HP MIXING TIPS
- Primary DI
- 00818524020493
- Version / Model
- VPS-8104
- Catalog Number
- VPS-8104
- Company Name
- CROWN DELTA CORPORATION
- Labeler DUNS
- 030479000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-05
- Public Version
- 4
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- c47e5fff-7c1a-4bfa-84a5-f788eeabf1c3
Device Description
M&S DENTAL IMPRESS-RITE HP MIXING TIPS (GREEN - 6.5MM) 48/BAG
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
- 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 |
|---|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58399 | Dental material mixing nozzle | A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818524020493 | GS1 | ||||
| Package | 10818524020490 | GS1 | BAG | 48 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 73 Degrees Fahrenheit