FDA UDI
In Commercial Distribution
🇺🇸 United States
DenBite
DI: 08717228440175
·
Model: DBU9098
·
DuPhaMed B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- DenBite
- Primary DI
- 08717228440175
- Version / Model
- DBU9098
- Company Name
- DuPhaMed B.V.
- Labeler DUNS
- 413491023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-11-24
- Public Version
- 1
- Public Version Date
- 2023-12-04
- Public Version Status
- New
- Public Device Record Key
- 2a338c2c-298f-4c33-b5b8-c6bc42805a63
Device Description
Wallmount basket for digital sensors, size 1 and size 2, black
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EGZ | Holder, Film, X-Ray | Dental | 872.1905 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16205 | Dental x-ray film holder, reusable | A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08717228440755 | GS1 | ||||
| Primary | 08717228440175 | GS1 |