FDA UDI
In Commercial Distribution
🇺🇸 United States
Hader Bar
DI: 00842092105382
·
Model: 0101704-6
·
Preat Corporation
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Hader Bar
- Primary DI
- 00842092105382
- Version / Model
- 0101704-6
- Catalog Number
- 0101704
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-28
- Public Version
- 5
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 3efb348b-e03b-4159-903d-991cee4e9f57
Device Description
Hader Plastic Bar Patterns (Standard)
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
- 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 |
|---|---|---|---|---|
| EHO | BAR, PREFORMED | Dental | 872.3165 | 1 |
| EGG | Attachment, Precision, All | Dental | 872.3165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31836 | Denture clasp mould | A prefabricated dental device intended to serve as a matrix or cavity for the casting of a metallic denture clasp. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842092105382 | GS1 | ||||
| Package | 00842092176351 | GS1 | 6 | In Commercial Distribution | ||
| Package | 10842092105389 | GS1 | 50 | In Commercial Distribution |