Primary Device ID | D746IS25110601 |
NIH Device Record Key | 96665a7f-a6bb-4e43-9c3a-8c1be3c041ca |
Commercial Distribution Discontinuation | 2018-03-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Ideal Clear |
Version Model Number | IS25-110-60 |
Catalog Number | IS25-110-60 |
Company DUNS | 801157132 |
Company Name | RAINTREE ESSIX INC. |
Device Count | 50 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com | |
Phone | +1(800)883-8733 |
sales@essix.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D746IS25110600 [Unit of Use] |
HIBCC | D746IS25110601 [Primary] |
MQC | Mouthguard, prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-07-22 |
Device Publish Date | 2016-09-24 |
D746IS25110801 | Ideal Clear 080 125MM Circle Biostar |
D746IS25110411 | Ideal Clear 040 120MM Circle Erko |
D746IS25110401 | Ideal Clear 040 125MM Circle Biostar |
D746IS25110201 | Ideal Clear 020 125MM Circle Biostar |
D746IS25110601 | Ideal Clear 060 125MM Circle Biostar |
D746IS25110311 | Ideal Clear 030 120MM Circle Erko |
D746IS25110301 | Ideal Clear 030 125MM Circle Biostar |
D746IS25100851 | Ideal Clear 080 127MM Square |
D746IS25100651 | Ideal Clear 060 127MM Square |
D746IS25100451 | Ideal Clear 040 127MM Square |
D746IS25100301 | Ideal Clear 030 125MM Square |
D746IS25100251 | Ideal Clear 020 127MM Square |