RINN®
- Primary DI
- D0035408531
- Brand
- RINN®
- Company
- Dentsply International Inc.
- Model
- 540853
- Catalog number
- 540853
- Device description
- UNIVERSAL COLLIMATOR
- Published
- 2017-04-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IZX | Collimator, manual, radiographic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IZX | Collimator, Manual, Radiographic | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D0035408531 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental x-ray system collimator | A beam restriction device used in dental x-ray systems to determine the dimension and direction of the x-ray beam, limiting the effects of scattered radiation. It is used to control the size and shape of the x-ray beam reaching the patient's oral cavity and the film or image receptor. It includes all kinds of x-ray beam restriction devices used in diagnostic dental x-ray systems, such as cones and slit collimators. The device is typically designed for use with a specific dental x-ray system. |
Regulatory Flags
- DUNS number
- 795572718
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| D0013010121 | Ceramco® 3 | Powder Opaque i2/i4 | 301012 | 2016-09-21 |
| D0013010211 | Ceramco® 3 | Powder Opaque D2 | 301021 | 2016-09-21 |
| D0013010311 | Ceramco® 3 | Powder Opaque Modifier Yellow | 301031 | 2016-09-21 |
| D0013010321 | Ceramco® 3 | Powder Opaque Modifier Sienna | 301032 | 2016-09-21 |
| D0013010361 | Ceramco® 3 | Powder Opaque Modifier Pink | 301036 | 2016-09-21 |
| D0013010371 | Ceramco® 3 | Powder Opaque Modifier Ochre | 301037 | 2016-09-21 |
| D0013010481 | Ceramco® 3 | Paste Opaque A3.5 | 301048 | 2016-09-21 |
| D0013010591 | Ceramco® 3 | Paste Opaque C2 | 301059 | 2016-09-21 |
| D0013010701 | Ceramco® 3 | Paste Opaque Modifiers White | 301070 | 2016-09-21 |
| D0013011031 | Ceramco® 3 | Opaceous Dentin i1 | 301103 | 2016-09-21 |
| D0013011071 | Ceramco® 3 | Opaceous Dentin A3.5 | 301107 | 2016-09-21 |
| D0013011101 | Ceramco® 3 | Opaceous Dentin i6 | 301110 | 2016-09-21 |
| D0013011181 | Ceramco® 3 | Opaceous Dentin C2 | 301118 | 2016-09-21 |
| D0013011221 | Ceramco® 3 | Opaceous Dentin D3 | 301122 | 2016-09-21 |
| D0013011501 | Ceramco® 3 | Dentin C4 | 301150 | 2016-09-21 |
| D0013011611 | Ceramco® 3 | Dentin Modifier A3.5 | 301161 | 2016-09-21 |
| D0013011671 | Ceramco® 3 | Dentin Modifier Blue | 301167 | 2016-09-21 |
| D0013012001 | Ceramco® 3 | Natural Enamel White | 301200 | 2016-09-21 |
| D0013012011 | Ceramco® 3 | Natural Enamel Extra Light | 301201 | 2016-09-21 |
| D0013013221 | Ceramco® 3 | Overglaze | 301322 | 2016-09-21 |
Other Devices Sharing Product Codes
xx.xx