FDA UDI
In Commercial Distribution
🇺🇸 United States
House Brand Dentistry
DI: 00810132802508
·
Model: HSB-300135
·
House Brand Dentistry
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- House Brand Dentistry
- Primary DI
- 00810132802508
- Version / Model
- HSB-300135
- Company Name
- House Brand Dentistry
- Labeler DUNS
- 203768304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-29
- Public Version
- 1
- Public Version Date
- 2024-02-06
- Public Version Status
- New
- Public Device Record Key
- 79f3cd89-6c1f-4489-8cd4-c98c61c63e93
Device Description
HSB - Root Canal Spreader S/E #D11T
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
- Yes
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37678 | Manual endodontic filling material spreader | A hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810132802508 | GS1 |