Aligned Medical Solutions

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

General surgery tray (LRO) (7) Angiography/angioplasty kit (OEQ) (1) Eye tray (OJK) (1) Orthopedic tray (OJH) (1)

Premarket Exempt

Yes

Clear

Aligned Medical Solutions - B09800132410 Catalog Number : 0013241

Device Description : Arthrogram Tray

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800132510 Catalog Number : 0013251

Device Description : Angiography Drape Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800132610 Catalog Number : 0013261

Device Description : Minor Procedure Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800136510 Catalog Number : 0013651

Device Description : Angio Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : OEQ

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800137200 Catalog Number : 0013720

Device Description : Cataract Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : OJK

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800206410 Catalog Number : 0020641

Device Description : Breast Biopsy Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800213630 Catalog Number : 0021363

Device Description : Ultrasound Percutaneous Core Kit

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800219740 Catalog Number : 0021974

Device Description : Minor Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B098002646130 Catalog Number : 00264613

Device Description : Minor Ortho Pack

Device Class : 1

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : OJH

Prescription Use : Yes

Device Count : 1

Aligned Medical Solutions - B09800294210 Catalog Number : 0029421

Device Description : Single Basin Pack

Device Class : 2

Duns Number: 106580145

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

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