FDA UDI
In Commercial Distribution
🇺🇸 United States
BOSWORTH
DI: H668166301
·
Model: 16630
·
Keystone Industries
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BOSWORTH
- Primary DI
- H668166301
- Version / Model
- 16630
- Catalog Number
- 16630
- Company Name
- Keystone Industries
- Labeler DUNS
- 073503117
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 2
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 3d3e420f-b1e6-44ce-ba4c-296954237012
Device Description
PROPHY POWDER STRAWBERRY(10OZ)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJR | AGENT, POLISHING, ABRASIVE, ORAL CAVITY | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45407 | Professional dental abrasive material | A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H668166301 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 284 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit