SPAN-AMERICA MEDICAL SYSTEMS, INC.

Address:70 Commerce Ctr,GREENVILLE,SC,29615,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

Mattress, Flotation Therapy, Non-Powered (IKY) (6) Mattress, Air Flotation, Alternating Pressure (FNM) (3) Cushion, Flotation (KIC) (1)

Premarket Exempt

Yes

Clear

Span-America - H93318200 Catalog Number : 18200

Device Description : GM PRO 80X35 NZ DBLSTCH

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93318352 Catalog Number : 18352

Device Description : GM PLUS DEMOW/FIRM PERIMETER

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93318471 Catalog Number :

Device Description : KIT PG EASY AIR 78X35 AUSTRALIA W/8210CEI

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93318555 Catalog Number : 18555

Device Description : GM 350 80X35X6-29 BAGGED

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93318632CE0 Catalog Number : 18632CE

Device Description : PG CFT 78X35X7 CE NO COVER

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

PressureGuard® - H9331863529 Catalog Number : 18635-29

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93318715 Catalog Number : 18715

Device Description : GM WINGS 80X35X6 W/PRS35 TOPPER

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

PressureGuard® - H93319459 Catalog Number : 19459

Device Description : Alternating Pressure Mattress

Device Class : 2

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Span-America - H93320114CE0 Catalog Number : 20114CE

Device Description : PG CFT 80X35X7 CE

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

Span-America - H93320211 Catalog Number : 20211

Device Description : GEL-T 16X16 PU ULTRA/BVINYL SACHRITOMA

Device Class : 1

Duns Number: 073704413

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

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