Primary Device ID | D764B10730921 |
NIH Device Record Key | a91bcb3e-58c1-407c-ab9f-a1b9fa49e985 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FONA CDR |
Version Model Number | B1073092 |
Company DUNS | 078613913 |
Company Name | SIRONA DENTAL, INC. |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
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 |
---|---|
HIBCC | D764B10730921 [Primary] |
EAP | Unit, X-Ray, Intraoral |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-03 |
Device Publish Date | 2016-09-09 |
D764B11120501 | FONA CDR SENSOR SIZE 1 SHIP KIT |
D764B10730921 | FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 2 |
D764B10730911 | FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 1 |
D764B10730701 | FONA CDR UNIVERSAL HOLDERS STARTER KIT |
D764B22521000 | FONA USB REMOTE ASSY |
D764B22520001 | FONA USB REMOTE SHIP KIT |
D764B13121000 | FONA CDR SENSOR SIZE 0 |
D764B13120501 | FONA CDR SENSOR SIZE 0 SHIP KIT |
D764B12121000 | FONA CDR SENSOR SIZE 2 |
D764B12120501 | FONA CDR SENSOR SIZE 2 SHIP KIT |
D764B11121000 | FONA CDR SENSOR SIZE 1 |