Henke-Sass, Wolf GmbH

Address:KELTENSTRASSE 1,TUTTLINGEN Baden-Wurttemberg,DE

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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

Irrigator, Powered Nasal (KMA) (6) Needle, Hypodermic, Single Lumen (FMI) (2) Syringe, Restorative And Impression Material (EID) (1)

Premarket Exempt

No Yes

Clear

Cleaning sheath for Ø3.1mm X 170mm 30° - 04035873069393 Catalog Number : 8300055825

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

Cleaning sheath for Ø3.1mm X 170mm 45° - 04035873069409 Catalog Number : 8300055826

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

Cleaning sheath for Ø3.1mm X 170mm 70° - 04035873069416 Catalog Number : 8300051358

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

Cleaning sheath for Ø3.1mm X 170mm 30° R - 04035873069423 Catalog Number : 8300055828

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

Cleaning sheath for Ø3.1mm X 170mm 45° R - 04035873069430 Catalog Number : 8300055829

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

Cleaning sheath for Ø3.1mm X 170mm 70° R - 04035873069447 Catalog Number : 8300052778

Device Description : cleaning sheath sinuscope

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : KMA

Prescription Use : No

Device Count : 1

IMPRESSION JET - 04035873069591 Catalog Number : 2930000240

Device Description : IMPRESSION JET

Device Class : 1

Duns Number: 317326411

Premarket Exempt : Yes

Product Code : EID

Prescription Use : Yes

Device Count : 1

HSW HENKE-JECT® - 04035873071105 Catalog Number : 8300059225

Device Description : HSW HENKE-JECT® 22G X 2 3/4 - 0,70 X 70 MM - RW /LB

Device Class :

Duns Number: 317326411

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 3000

HSW HENKE-JECT® - 04035873071136 Catalog Number : 8300059226

Device Description : HSW HENKE-JECT® 22G X 4 - 0,70 X 100 MM - RW /LB

Device Class :

Duns Number: 317326411

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

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