FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040128503
·
Model: 1018780
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040128503
- Version / Model
- 1018780
- Catalog Number
- 1018780
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-04
- Public Version
- 1
- Public Version Date
- 2020-08-12
- Public Version Status
- New
- Public Device Record Key
- 9a4f7592-5ce2-453c-a745-92baa79d6790
Device Description
Burnisher DE 21B
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKJ | BURNISHER, OPERATIVE | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64078 | Manual dental burnisher, reusable | A hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040128503 | GS1 |