FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040051853
·
Model: 9000764
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
48
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040051853
- Version / Model
- 9000764
- Catalog Number
- 9000764
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2017-03-30
- Public Version
- 3
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 04e4e245-fb3b-4a56-86c8-7622e2bf0c11
Device Description
HP Mixing Tip Yellow Small 4.2mm
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 20304040051850 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 10304040051853 | GS1 | ||||
| Unit of Use | 00304040051856 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- N/A