FDA UDI
In Commercial Distribution
🇺🇸 United States
ALMORE BITE REGISTRATION TABS
DI: D248426021
·
Model: 42602
·
HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
125
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Basic Information
- Brand Name
- ALMORE BITE REGISTRATION TABS
- Primary DI
- D248426021
- Version / Model
- 42602
- Company Name
- HAGER WORLDWIDE, INC.
- Labeler DUNS
- 009277971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- e11932ba-c591-46e7-8fb7-f98a07fcf0bc
Device Description
BITE REGISTRATION TABS
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D2484260200 | HIBCC | ||||
| Primary | D248426021 | HIBCC |
Customer Contacts
- Phone
- +1(828)624-3319
- [email protected]