Primary Device ID | 09010522000861 |
NIH Device Record Key | 6aae81c1-8d7c-4217-aa86-821ff75c6b8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Osstell Beacon Instrument |
Version Model Number | Osstell Osstell Beacon Instrument |
Catalog Number | 100668 |
Company DUNS | 633171269 |
Company Name | Osstell 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 | true |
Manufacturing Date | true |
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 | 09010522000861 [Package] Contains: 09010522000885 Package: Box [1 Units] In Commercial Distribution |
GS1 | 09010522000878 [Package] Package: Box DEMO [1 Units] In Commercial Distribution |
GS1 | 09010522000885 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-12 |
Device Publish Date | 2022-09-02 |
09010522002469 - Neoss SmartPeg Mount | 2023-12-14 SmartPeg Mount |
09010522002087 - Osstell SmartPeg Type 99 | 2023-11-09 |
09010522002117 - Osstell SmartPeg Type 100 | 2023-11-09 ISQ Measurement Peg |
09010522002131 - Osstell SmartPeg Type 101 | 2023-11-09 ISQ Measurement Peg |
09010522002155 - Osstell SmartPeg Type 102 | 2023-11-09 ISQ Measurement Peg |
09010522002162 - Osstell SmartPeg Type 103 | 2023-11-09 ISQ Measurement Peg |
09010522002186 - Osstell SmartPeg Type 104 | 2023-11-09 ISQ Measurement Peg |
09010522002223 - Osstell SmartPeg Type 106 | 2023-11-09 ISQ Measurement Peg |