Primary Device ID | B098PS1001 |
NIH Device Record Key | 44f75495-78c8-4b60-a065-bb31db180b39 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aligned Medical Solutions |
Version Model Number | PS100 |
Catalog Number | PS100 |
Company DUNS | 106580145 |
Company Name | Aligned Medical Solutions |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | true |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(888)637-7056 |
customerservice@alignedmedicalsolutions.com | |
Phone | +1(888)637-7056 |
customerservice@alignedmedicalsolutions.com |
Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B098PS1000 [Primary] |
HIBCC | B098PS1001 [Package] Contains: B098PS1000 Package: case [30 Units] In Commercial Distribution |
MYK | Kit, cord blood collection |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-09-23 |
Device Publish Date | 2018-11-14 |
B09800109121 | Goller ER Tray-RX |
B09800107411 | Port Tray - RX |
B098001072101 | Large Pack |
B09800107171 | Face Pack |
B09800106821 | SAVI Procedure Kit |
B09800104551 | Shoulder Arthroscopy Pack |
B09800103101 | Mosquito Curved Forcep |
B09800101361 | Knee Arthroscopy Pack |
B098AMSSSKIT1 | Shoulder Suspension System Kit |
B098AMS6619A1 | Podiatry Pack |
B098AMS66101 | Cysto Pack |
B098AMS66091 | Vasectomy Pack |
B098AMS6606B1 | Pain Management Tray |
B098AMS6606A1 | Pain Management Tray |
B098AMS6605A1 | Shoulder Arthro Pack |
B098AMS6604A1 | Cysto/U-Scope Pack |
B098AMS6603A1 | Open Shoulder Pack |
B098AMS6602A1 | Lower Extremity Pack |
B098AMS6601B1 | Knee Arthro Video Pack |
B098AMS6600A1 | General Laparoscopic Pack |
B098AMS6599B1 | Hand Pack |
B098AMS65991 | Hand Pack |
B098AMS6598A1 | Head and Neck Pack |
B098AMS65971 | Minor Pack |
B098AMS65961 | VCA Smoketown Pack |
B098AMS65881 | Arthroscopy Pack |
B098AMS65871 | Hand Pack |
B098AMS65851 | Extremity Pack |
B098AMS6584A1 | Laparotomy Pack |
B098AMS6583B1 | Shoulder Pack |
B098AMS6582A1 | Knee Pack |
B098AMS65731 | Bone Marrow Pack (11862) |
B098AMS6572A1 | Breast Biopsy Pack (24771) |
B098AMS65721 | Breast Biopsy Pack (24771) |
B098AMS6571A1 | Angio Pack (22750) |
B098AMS65711 | Angio Pack (22750) |
B098AMS6570A1 | Minor Procedure Pack (20527) |
B098AMS65691 | Ports Cath Pack (1794) |
B098AMS6568A1 | Cysto Pack (1343) |
B098AMS65681 | Cysto Pack (1343) |
B098AMS6567B1 | Lap Chole Pack (6037) |
B098AMS6566B1 | Lap Minor Pack (1346) |
B098AMS6566A1 | Lap Minor Pack (1346) |
B098AMS6565B1 | Major Pack (1345) |
B098AMS6564B1 | Hip Pack (1347) |
B098AMS6563B1 | Total Knee Pack (15710) |
B098AMS6562B1 | Laparoscopy Pack (1184) |
B098AMS6561B1 | Extremity Pack (1344) |
B098AMS6560A1 | Basic Pack (1185) |
B098AMS6559B1 | Arthroscopy Pack (1181) |