Gentherm Medical, LLC

Address:12011 MOSTELLER RD,Cincinnati,OH,45241,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) (10)

Premarket Exempt

No Yes

Clear

Plastipad® Narrow Adult/OR Table Size - 10613031501032 Catalog Number : 50103

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Plastipad® Pediatric Size - 10613031501117 Catalog Number : 50111

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Cold Therapy Temp-Pads® - 10613031507157 Catalog Number : 50715

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : No

Device Count : 1

Plastipad® Adult Size - 10613031821840 Catalog Number : 82184

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Plastipad® Infant Size - 10613031821925 Catalog Number : 82192

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Plastipad® Infant Size - 10613031821932 Catalog Number : 82193

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Plastipad® Pediatric Size - 10613031821949 Catalog Number : 82194

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Plastipad® Adult or OR Table Size - 10613031821963 Catalog Number : 82196

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Gelli-Roll® Infant Size - 10613031821970 Catalog Number : 82197

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

Gelli-Roll® Pediatric Size - 10613031821987 Catalog Number : 82198

Device Description : Water Circulating Hot or Cold Pack

Device Class : 2

Duns Number: 004249462

Premarket Exempt : Yes

Product Code : ILO

Prescription Use : Yes

Device Count : 1

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