Primary Device ID | 00732224720289 |
NIH Device Record Key | 05d9afb9-e231-479d-b4d9-a4bf3c400692 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Single Species BI Strip |
Version Model Number | BS-107 |
Catalog Number | BS-107 |
Company DUNS | 057728685 |
Company Name | CROSSTEX INTERNATIONAL, INC. |
Device Count | 100 |
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 | 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)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com | |
Phone | +1(585)359-0130 |
regulatoryaffairs@hu-friedy.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00732224720289 [Unit of Use] |
GS1 | 10732224720286 [Primary] |
FRC | Indicator, biological sterilization process |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-04 |
Device Publish Date | 2024-03-27 |
00732224720432 | Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes |
00732224720333 | Bacillus atrophaeus 10e8 strip for EO Gas and Dry Heat sterilization processes |
00732224720326 | Bacillus atrophaeus 10e7 strip for EO Gas and Dry Heat sterilization processes |
00732224720319 | Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes |
00732224720302 | Bacillus atrophaeus 10e6 strip for Dry Heat sterilization processes |
00732224720296 | Geobacillus stearothermophilus 10e8 strip for Steam sterilization processes |
00732224720289 | Geobacillus stearothermophilus 10e7 strip for Steam sterilization processes |
00732224720272 | Geobacillus stearothermophilus 10e6 strip for Steam sterilization processes |
00732224720234 | Geobacillus stearothermophilus 10e5 strip for Steam sterilization processes |
00732224720227 | Geobacillus stearothermophilus 10e6 strip for Steam sterilization processes |
00732224720210 | Geobacillus stearothermophilus 10e5 strip for Steam sterilization processes |