FDA UDI
In Commercial Distribution
🇺🇸 United States
Bosworth TruRepair
DI: H6680921641
·
Model: 092164
·
Harry J Bosworth Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bosworth TruRepair
- Primary DI
- H6680921641
- Version / Model
- 092164
- Catalog Number
- 092164
- Company Name
- Harry J Bosworth Company
- Labeler DUNS
- 014769301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 662f6c99-e127-42ee-9981-15a546fe911e
Device Description
4 oz Repair Liquid
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11171 | Denture repair kit, professional | A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H6680921641 | HIBCC |
Customer Contacts
- Phone
- +1(800)333-3131 ext. 8455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Fluid Ounce | |
| Total Volume | 118 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from moisture
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight