Primary Device ID | 07350081495077 |
NIH Device Record Key | a0615ec7-998d-4725-ada0-64a304f43d95 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Anew Implant System |
Version Model Number | ST-18S |
Company DUNS | 355803412 |
Company Name | Dentatus AB |
Device Count | 1 |
DM Exempt | false |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +46854650900 |
info@dentatus.se |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07350081494650 [Package] Package: Implant pack [2 Units] In Commercial Distribution |
GS1 | 07350081494667 [Package] Package: Implant pack [1 Units] In Commercial Distribution |
GS1 | 07350081495077 [Primary] |
DZE | Implant, Endosseous, Root-Form |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-08-20 |
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