Primary Device ID | 07332747149487 |
NIH Device Record Key | 3f2ded32-d81f-45f4-8387-6430ce627e0d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DTX Studio design |
Version Model Number | 300160_V1.7_WIN64 |
Catalog Number | 300160_V1.7_WIN64 |
Company DUNS | 353939929 |
Company Name | Nobel Biocare AB |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07332747149487 [Primary] |
NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-05-31 |
Device Publish Date | 2018-02-02 |
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