SVS LLC

Address:13034 Ballantyne Corporate Pl,Charlotte,NC,28277,US

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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

Pack, Hot Or Cold, Water Circulating (ILO) (6) Garment, Protective, For Incontinence (EYQ) (2) Patient Examination Glove, Specialty (LZC) (1) Polymer Patient Examination Glove (LZA) (1) Stethoscope, Manual (LDE) (1)

Premarket Exempt

No Yes

Clear

PremierPro - 00811220030100 Catalog Number : 1243PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Universal Knee/Shoulder, Non-Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030117 Catalog Number : 1244PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Universal Knee/Shoulder, Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030124 Catalog Number : 1245PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Knee with Attached Straps, Non-Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030131 Catalog Number : 1246PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Knee with Attached Straps, Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030148 Catalog Number : 1247PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Shoulder with Attached Straps, Non-Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030155 Catalog Number : 1248PP

Device Description : PremierPro Cold Therapy Unit + Blanket Combo, Shoulder with Attached Straps, Sterile

Device Class : 2

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

PremierPro - 00811220030278 Catalog Number : 6355

Device Description : Dual-Head Stethoscope Pediatric, Gray

Device Class : 1

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : LDE

Prescription Use : No

Device Count : 1

PremierPro - 00811220030285 Catalog Number : 3648

Device Description : Seamless Knit Pants, Large/X-Large, Green, 2/bg, 50bgs/case

Device Class : 1

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

PremierPro - 00811220030292 Catalog Number : 3649

Device Description : Seamless Knit Pants, 2XL/3XL, Purple, 2/bg, 50bgs/case

Device Class : 1

Duns Number: 831375089

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

PremierPro - 00811220030308 Catalog Number : 5001

Device Description : PremierPro PF Enhanced Chemo Tested Nitrile Exam Glove X-Small 250count

Device Class : 1

Duns Number: 831375089

Premarket Exempt : No

Product Code : LZC, LZA

Prescription Use : No

Device Count : 1

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