As part of our commitment to meeting MDR standards, we are implementing an important update to our BioMIM, H4 and Pitts21 case labels. Starting November 15, 2024, we will be adding the following information to the case labels:
- UDI Barcode
- Manufacture Date
- Product logo
This update will ensure that each individual case label fully complies with MDR requirements. As a result, we will no longer be applying an additional label to the outside of the shrink-wrapped stacks.
Exceptions: Part Numbers 916.2155 and 946.2155
For part numbers 916.2155 and 946.2155, there will be no changes to the current label and the label will continue to be applied to the outside of the shrink wrap.
916.2155 consists of 916.2151 (lowers only case) and 916.2152 (uppers only case), which are shrink-wrapped together.
946.2155 consists of 946.2151 (lowers only case) and 946.2152 (uppers only case), which are also shrink-wrapped together.
Please refer to the examples below, which illustrate the label changes. If you have any questions or concerns regarding this update, feel free to contact me at ashley.s@oc-orthodontics.com.
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