| Primary Device ID | B098AMS13257B1 |
| NIH Device Record Key | bb64ddd9-e619-412d-9284-082bf0087b1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aligned Medical Solutions |
| Version Model Number | AMS13257B |
| Catalog Number | AMS13257B |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B098AMS13257B0 [Primary] |
| HIBCC | B098AMS13257B1 [Package] Contains: B098AMS13257B0 Package: CASE [20 Units] In Commercial Distribution |
| LRO | General Surgery Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-16 |
| Device Publish Date | 2024-10-08 |
| 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) |