HARTMANN USA, INC.

Address:481 LAKESHORE PKWY.,ROCK HILL,SC,29730,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) (5) Gauze / Sponge,Nonresorbable For External Use (NAB) (1)

Premarket Exempt

Yes

Clear

Cosmopor silicone 10x8cm P10 - 04052199572345 Catalog Number :

Device Description : Cosmopor silicone 10x8cm P10

Device Class : 1

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Cosmopor silicone 7,2x5cm P10 - 04052199572376 Catalog Number :

Device Description : Cosmopor silicone 7,2x5cm P10

Device Class : 1

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Cosmopor silicone 20x10cm P10 - 04052199572437 Catalog Number :

Device Description : Cosmopor silicone 20x10cm P10

Device Class : 1

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Cosmopor silicone 15x8cm P10 - 04052199572468 Catalog Number :

Device Description : Cosmopor silicone 15x8cm P10

Device Class : 1

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Omnifix silicone, 10cmx5m, P1 - 04052199575940 Catalog Number :

Device Description : Omnifix silicone, 10cmx5m, P1

Device Class : 1

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

SORBALUX ABD PAD ST 3x5 400/CS - 04052199583587 Catalog Number :

Device Description : SORBALUX ABD PAD ST 3x5 400/CS

Device Class :

Duns Number: 010137511

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

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