Primary Device ID | D746UFS080X5R1 |
NIH Device Record Key | b5a4ab39-b534-42c9-bf64-1631e47d7d3c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Round ultrafit |
Version Model Number | UFS080X5R |
Catalog Number | UFS080X5R |
Company DUNS | 801157132 |
Company Name | RAINTREE ESSIX INC. |
Device Count | 5 |
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 | |
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 | D746UFS080X5R0 [Unit of Use] |
HIBCC | D746UFS080X5R1 [Primary] |
MQC | Mouthguard, prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-07-22 |
Device Publish Date | 2016-09-24 |
D746UFS080X5R1 | Round ultrafit sheets .080" 5-pack |
D746UFS080X25R1 | Round ultrafit sheets .080"x125mm. 25-pack |
D746UFS060X5R1 | Round ultrafit sheets .060" 5-pack |
D746UFS060X50R1 | Round ultrafit sheets .060" 50-pack |
D746UFS060X25R1 | Round ultrafit sheets .060"x125mm. 25-pack |
D746UFS040X10R1 | Round ultrafit sheets .040"x125mm. 10-pack |
D746UFS040X100R1 | Round ultrafit sheets .040"x125mm. 100-pack |