GF HEALTH PRODUCTS, INC.

Address:336 Trowbridge Dr,Fond du Lac,WI,54937,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

Tape And Bandage, Adhesive (KGX) (4) Lift, Patient, Non-Ac-Powered (FSA) (3) Lift, Patient, Ac-Powered (FNG) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (1)

Premarket Exempt

No Yes

Clear

Lumex - M368STS5001 Catalog Number : STS500

Device Description : Lift Sit To Stand Battery Powered

Device Class : 2

Duns Number: 132016168

Premarket Exempt : Yes

Product Code : FNG

Prescription Use : No

Device Count : 1

Lumex - M368STS500M1 Catalog Number : STS500M

Device Description : Lift Sit to Stand

Device Class : 2

Duns Number: 132016168

Premarket Exempt : Yes

Product Code : FNG

Prescription Use : No

Device Count : 1

LUMISCOPE - M368SW10001 Catalog Number :

Device Description : Standard TENS Unit

Device Class : 2

Duns Number: 132016168

Premarket Exempt : No

Product Code : GZJ

Prescription Use : No

Device Count : 1

LUMEX - M368UMH8321 Catalog Number : UMH832

Device Description : UNIVERSAL SLG HD SPT MESH MED

Device Class : 1

Duns Number: 132016168

Premarket Exempt : Yes

Product Code : FSA

Prescription Use : No

Device Count : 1

GRAFCO - M368UNNA31 Catalog Number :

Device Description : UNNA'S Boot Dressing

Device Class : 1

Duns Number: 132016168

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 1

GRAFCO - M368UNNA41 Catalog Number :

Device Description : UNNA'S Boot Dressing

Device Class : 1

Duns Number: 132016168

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 1

GRAFCO - M368UNNAC31 Catalog Number :

Device Description : UNNA'S Boot Dressing with Calamine

Device Class : 1

Duns Number: 132016168

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 1

GRAFCO - M368UNNAC41 Catalog Number :

Device Description : UNNA'S Boot Dressing with Calamine

Device Class : 1

Duns Number: 132016168

Premarket Exempt : No

Product Code : KGX

Prescription Use : No

Device Count : 1

LUMEX - M368UP8921 Catalog Number : UP892

Device Description : SLING UNIVERSAL MEDIUM

Device Class : 1

Duns Number: 132016168

Premarket Exempt : Yes

Product Code : FSA

Prescription Use : No

Device Count : 1

Lumex - M368UP8931 Catalog Number : UP893

Device Description : SLING UNIVERSAL LARGE

Device Class : 1

Duns Number: 132016168

Premarket Exempt : Yes

Product Code : FSA

Prescription Use : No

Device Count : 1

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