FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal
DI: D003B10730521
·
Model: B1073052
·
Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Universal
- Primary DI
- D003B10730521
- Version / Model
- B1073052
- Catalog Number
- B1073052
- Company Name
- Dentsply International Inc.
- Labeler DUNS
- 795572718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-11-06
- Public Version
- 1
- Public Version Date
- 2024-11-14
- Public Version Status
- New
- Public Device Record Key
- 9dcd1d6c-24a7-4bf1-aaa6-8d32fef83fa5
Device Description
UNIVRSL BITEWING HLDR ASSY KIT BLUE
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
- Yes
- 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 | D003B10730520 | HIBCC | ||||
| Primary | D003B10730521 | HIBCC |