FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040169817
·
Model: 5703321
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
150
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040169817
- Version / Model
- 5703321
- Catalog Number
- 5703321
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2023-08-30
- Public Version
- 1
- Public Version Date
- 2023-09-07
- Public Version Status
- New
- Public Device Record Key
- 39bc650e-448e-4693-accd-0e526356f4f3
Device Description
Gutta Percha Cadmium Free
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EKM | GUTTA-PERCHA | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31872 | Natural gutta-percha | A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040169810 | GS1 | ||||
| Primary | 10304040169817 | GS1 |