Primary Device ID | 30732224001754 |
NIH Device Record Key | fb682a1c-85a6-4554-aa0d-362ce73748a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Articulating Paper |
Version Model Number | TPBR |
Company DUNS | 057728685 |
Company Name | CROSSTEX INTERNATIONAL, INC. |
Device Count | 12 |
DM Exempt | true |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0167 |
regulatoryaffairs@hu-friedy.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00732224001753 [Unit of Use] |
GS1 | 10732224001750 [Primary] |
GS1 | 30732224001754 [Package] Contains: 10732224001750 Package: [12 Units] In Commercial Distribution |
EFH | PAPER, ARTICULATION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-07 |
Device Publish Date | 2022-09-29 |
30732224001785 | Horseshoe Articulating Paper, Blue Red Combo, 0.0035"/89 µm |
30732224001754 | Articulating Paper, Blue Red Combo, 0.0028"/71 µm |
30732224001747 | Articulating Paper, Thin Blue 0.0028"/71 µm |
30732224001716 | Articulating Paper,Thick Blue 0.005"/127 µm |
30732224001723 | Articulating Paper, XX Thin, Blue 0.00125"/32 µm |
10732224001736 | Articulating Paper,Thick Blue 0.005"/127 µm |