FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 20304040003323
·
Model: 1024809
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
4
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 20304040003323
- Version / Model
- 1024809
- Catalog Number
- 1024809
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1076bc02-b3a0-44f2-b0fa-9ad5efad0ac9
Device Description
VP Mix HP Fast Set
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10304040003326 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 20304040003323 | GS1 | ||||
| Package | 30304040003320 | GS1 | SHIPPER | 4 | In Commercial Distribution | |
| Unit of Use | 00304040003329 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 73 Degrees Fahrenheit