Primary Device ID | B971VF100 |
NIH Device Record Key | 4a09ce81-8d3e-4025-8f27-383f0151cd5e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DentalMark |
Version Model Number | DentalMark 1.0mm Visionline ball for Cone Beam CT |
Company DUNS | 055127831 |
Company Name | Jessop Precision Products Inc. |
Device Count | 110 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | false |
OTC Over-The-Counter | false |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com | |
Phone | 800-406-3399 |
orders@suremark.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B971VF100 [Unit of Use] |
HIBCC | B971VF101 [Primary] |
JAC | System, X-Ray, Film Marking, Radiographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-18 |
Device Publish Date | 2021-10-08 |
B971VF200 | DentalMark 2.0mm Visionline ball on denture sized |
B971VF100 | DentalMark 1.0mm Visionline ball for Cone Beam CT |
B971SF100 | DentalMark 1.0mm lead ball for conventional Cephal |
B971DM80 | DentalMark 2.0mm flat fiducial markers |
B971CF230 | 2.3mm CT ball on denture sized label |