FDA UDI
In Commercial Distribution
🇺🇸 United States
Bite Rim Sticks
DI: 04582275712407
·
Model: sample L, LIGHT PINK
·
YAMAHACHI DENTAL MFG.,CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bite Rim Sticks
- Primary DI
- 04582275712407
- Version / Model
- sample L, LIGHT PINK
- Company Name
- YAMAHACHI DENTAL MFG.,CO.
- Labeler DUNS
- 693430001
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-29
- Public Version
- 1
- Public Version Date
- 2021-05-07
- Public Version Status
- New
- Public Device Record Key
- e6c82c3a-3c66-4551-b5f7-2a740b3c5a52
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGD | Wax, Dental, Intraoral | Dental | 872.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38602 | Bite registration rim wax | A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04582275712407 | GS1 |